Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a…
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to…
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
March 5, 2025SIGNA Creator… and 4 more productsClass IIFor certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR…
Dec. 11, 2024GE Healthcare Discovery RT… and 16 more productsClass IIGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades…
Dec. 4, 2024GE Proteus XR/A radiographic systemClass IISteel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the…
Oct. 2, 2024GE Healthcare Centricty PACS…Class IIGE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image…
Sept. 25, 2024ViewPoint… and 1 more productClass IIThe National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth…
Sept. 4, 2024GE Healthcare Proteus XR/a…Class IIThe XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation…
Nov. 1, 2023Centricity PACS-IW… and 2 more productsClass IIGE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity…
Aug. 17, 2022Service manuals for the CT…Class IIAs a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the…
Aug. 3, 2022Centricity PACS Software Version 7.0 SP0.0.4.7Class IIThe Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post…
July 27, 2022SIGNA Premier magnetic resonance scanner…Class IIUnder rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated…
July 27, 2022GE Healthcare Avance CS2…Class IIThe base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This…
June 22, 2022CARESCAPE Central Station (CSCS) V2…Class IIThe CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring…
April 27, 2022GE Healthcare MR Systems…Class IIDuring the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly…
April 20, 2022MUSE Cardiology Information System…Class IITwo scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
April 13, 2022Revolution Apex… and 1 more productClass IIThe accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being…
Feb. 2, 2022GE Vscan Extend… and 6 more productsClass IIThe firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to…
Dec. 1, 2021Computed Tomography Systems Revolution CT…Class IIThe accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table…
Oct. 13, 2021Centricity Universal Viewer 7.0…Class IIA software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the…
Oct. 6, 2021AMX Navigate Mobile X-Ray SystemClass IIAn unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Aug. 4, 2021CARESCAPE PDM-Masimo SpO2…Class IIMasimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
July 21, 2021SIGNA Premier… and 13 more productsClass IIGE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be…
July 14, 2021Revolution CTClass IIGE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position.…
July 7, 2021Revolution EVO…Class IIImproperly loaded software options may result in additional X -ray radiation exposure to the patient.
June 23, 2021GE Healthcare Innova IGS 3 (GTIN 00840682147378)…Class IIThe IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two…
May 12, 2021Centricity Universal Viewer…Class IIWhen the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist…
Feb. 24, 2021System… and 1 more productClass IIGE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems…
Feb. 17, 2021GE Healthcare Precision 600FP…Class IIGE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A…
Dec. 30, 2020Revolution CT ES… and 1 more productClass IIA potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Nov. 4, 2020Revolution Apex…Class IIThere is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Oct. 28, 2020System… and 4 more productsClass IIPotential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Aug. 12, 2020Carescape One…Class IICARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to…
June 10, 2020System… and 1 more productClass IIGE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a…
June 3, 2020Giraffe Shuttle…Class IIDuring Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
May 6, 2020Lunar iDXA bone densitometer and 3 more productsClass IIAn issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Jan. 29, 2020Centricity Universal Viewer 6.0…Class IICentricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing…
Jan. 22, 2020CARESCAPE Respiratory Module E-sCO and 6 more productsClass IDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the…
Jan. 1, 2020ApexPro Telemetry System… and 2 more productsClass IIWhen connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro…
Dec. 25, 2019Aestiva MRI… and 3 more productsClass IICertain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An…
Dec. 11, 2019Giraffe OmniBed infant warmer and 3 more productsClass IGiraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed…
Nov. 13, 2019Giraffe OmniBed Carestation CS1…Class IIFasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Nov. 6, 2019CardioLab/ComboLab Recording SystemsClass IIPotential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation…
Oct. 30, 2019ApexPro Telemetry Server System…Class IIMay not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS…
Oct. 16, 2019Achilles Insight Bone Sonometer and 1 more productClass IICertain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin…
Oct. 16, 2019AIR Technology Anterior Array…Class IIThe outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user…
Oct. 2, 2019Proteus XR/a (SlOK : K993090)Class IIIntermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
July 31, 2019Mac Vu360…Class IITwo issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s…
June 26, 2019LVivo EF app on Vscan Extend…Class IIOverestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
June 19, 2019Prestige II… and 4 more productsClass IIThere has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
April 24, 2019Innova IGS 630… and 2 more productsClass IIThere is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while…
April 17, 2019Thallous Chloride TI 201 Injection…Class IIIChemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Dec. 26, 2018Omnipaque (iohexol) Injection…Class IIDefective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance…
Dec. 26, 2018Centricity Universal Viewer Zero Footprint Client…Class IIIssue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and…
Dec. 19, 2018Discovery NM/CT 670 DR… and 2 more productsClass IIWhen your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not…
Dec. 19, 2018GE LOGIQ E10 Ultrasound System…Class IIThere is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Dec. 12, 2018GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard…Class IThe ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation…
Nov. 21, 2018Aisys Anesthesia System… and 2 more productsClass IIUpgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode…
Aug. 8, 2018Discovery IQ 2.0 20cm… and 9 more productsClass IISome CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS…
Aug. 1, 2018Brivo XR385…Class IIThe placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in…
April 11, 2018GE Healthcare Centricity PACS-IW…Class IIA database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW.…
April 11, 2018Uterine Electromyographic Monitor… and 1 more productClass IIif the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate…
July 19, 2017Carestation 620 A1…Class IICarestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
June 21, 2017Infant Warmer System (IWS)Class IIGE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot…
June 7, 2017Table Patient Step on RFX/SFX…Class IIReported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a…
April 19, 2017Vivid E95/E90/E80… and 1 more productClass IIGE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM…
Jan. 18, 2017Infant Warmer System (IWS)Class IIGE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot…
Jan. 4, 2017Innova 2000 and 12 more productsClass IIGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX…
Dec. 21, 2016GE Healthcare…Class IIGE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System…
Sept. 14, 2016GE Healthcare SIGNA Creator…Class IIGE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could…
July 13, 2016GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore…
June 15, 2016MSK 1.5T Extreme MR Scanner… and 1 more productClass IIThe gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen…
June 15, 2016GE Revolution CT The system is intended for head…Class IIGEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large…
Nov. 18, 2015GE Healthcare… and 6 more productsClass IIWhen performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling.…
Sept. 30, 2015Lightspeed 16 CT and 2 more productsClass IIPotential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Aug. 12, 2015GE Healthcare…Class IIA gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X…
July 8, 2015GE Healthcare Optima IGS 320… and 12 more productsClass IIGE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic…
July 1, 2015GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
June 3, 2015D-fend…Class IIA potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway…
May 27, 2015CT LightSpeed 16 and Discovery ST Pet/CT DST…Class IIGE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16…
May 20, 2015GE Healthcare…Class IIThe heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM…
May 13, 2015GE Discovery MR950 MRI systemClass IIThe alignment lasers are missing the labels required by radiation safety regulations.
April 8, 2015GE Healthcare…Class IISpecific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or…
April 1, 2015GE Healthcare…Class IIGE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
March 25, 2015GE Healthcare…Class IIPotential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
March 25, 2015GE Healthcare Millennium VG…Class IIGE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while…
March 25, 2015GE Healthcare Engstrom Carestation…Class IIPotential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
Jan. 21, 2015GE Healthcare Revolution CT…Class IIPotential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
Jan. 21, 2015GE Healthcare…Class IIPotential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
Jan. 21, 2015GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in…
Oct. 15, 2014GE Healthcare Carescape Patient Data ModuleClass IIGE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient…
Oct. 8, 2014GE Healthcare Precision 500D…Class IIGE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly…
Sept. 17, 2014CARESCAPE Respiratory Modules E-sCO…Class IIGE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE…
Aug. 27, 2014GE Healthcare…Class IIGE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall…
July 30, 2014GE Healthcare…Class IIPossible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB…
July 30, 2014GE Healthcare…Class IIPartial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650…
July 30, 2014Datex-Ohmeda S/5 Single-Width Airway Module…Class IFailure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values.…
July 9, 2014GE Healthcare… and 1 more productClass IIGE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the…
June 25, 2014GE Healthcare…Class IIPotential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may…
May 28, 2014GE Healthcare…Class IIWhen the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of…
May 7, 2014GE Healthcare Discovery MR450…Class IIGE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or…
May 7, 2014GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow…
April 30, 2014GE Vivid E9 Ultrasound System…Class IIGE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D…
April 30, 2014GE Healthcare…Class IIPotential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections…
March 19, 2014GE Healthcare…Class IIGE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays…
March 12, 2014GE Healthcare…Class IIWhen performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI…
March 5, 2014GE Healthcare… and 2 more productsClass IOxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Feb. 26, 2014GE Healthcare…Class IIGE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops…
Feb. 26, 2014GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of…
Feb. 12, 2014CARESCAPE Monitor B850…Class IIThere is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE…
Feb. 12, 2014Giraffe¿ Infant Warmers… and 5 more productsClass IIMedical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Feb. 12, 2014GE Healthcare Precision 500D…Class IIGE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems…
Feb. 5, 2014GE Healthcare Innova IGS 630…Class IIGE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a…
Jan. 29, 2014GE Healthcare… and 2 more productsClass IIIntermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May…
Dec. 25, 2013Multi Absorber Original…Class IGE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Dec. 18, 2013HGE Healthcare Patient Monitor B30…Class IIGE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient…
Nov. 27, 2013GE Vivid E9 ultrasound system…Class IIGE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system.…
Nov. 27, 2013GE Healthcare Discovery NMCT 670…Class IIGE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the…
Nov. 20, 2013AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.)…Class IIGE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer…
Oct. 23, 2013GE… and 1 more productClass IIGE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which…
Oct. 23, 2013GE Healthcare…Class IIGE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova…
Oct. 23, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the…
Oct. 23, 2013GE Healthcare…Class IGE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the…
Oct. 23, 2013GE Healthcare…Class IGE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating…
Oct. 9, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750…
Oct. 2, 2013GE 1.5T Signa HDxt…Class IIGE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR…
Sept. 25, 2013GE Healthcare…Class IIGE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain…
Sept. 25, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have…
Sept. 25, 2013GE Healthcare…Class IIGE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be…
Sept. 25, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must…
Sept. 4, 2013GE Healthcare… and 2 more productsClass IIGE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with…
Sept. 4, 2013GE Ultrasound ViewPoint 6…Class IIGE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow…
Aug. 28, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems.…
Aug. 21, 2013GE Healthcare…Class IIGE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This…
Aug. 21, 2013GE Healthcare…Class IIGE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic…
Aug. 7, 2013GE Healthcare…Class IIGE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the…
Aug. 7, 2013GE Healthcare…Class IIGE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which…
July 10, 2013GE Healthcare…Class IIGE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova…
July 3, 2013GE Healthcare Senographe Essential System…Class IIGE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual…
June 26, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in…
May 22, 2013GE Healthcare Innova 2100 IQ…Class IIWhile performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance…
May 8, 2013GE Healthcare… and 2 more productsClass IIGE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from…
May 8, 2013GE…Class IIFastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the…
May 1, 2013Ventri Discovery NM 530c…Class IIGE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a…
May 1, 2013GE Healthcare…Class IIGE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may…
April 24, 2013GE Healthcare…Class IIAs part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is…
April 24, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results…
April 24, 2013GE Healthcare Muse v7 cardiology information system…Class IIGE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
April 17, 2013GE Healthcare…Class IIGE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of…
April 17, 2013VMX…Class IIGE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems…
April 17, 2013GE Healthcare Quasar Nuclear Medicine System…Class IIAccelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure…
March 20, 2013GE Healthcare Advantx…Class IIA locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova…
March 20, 2013Optima MR450w…Class IIAn error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
March 20, 2013GE Healthcare…Class IIExposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable…
Feb. 20, 2013GE Healthcare…Class IIGE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that…
Feb. 20, 2013GE Healthcare…Class IIGE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2…
Feb. 20, 2013GE Healthcare…Class IIGE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the…
Feb. 20, 2013GE Healthcare… and 1 more productClass IOxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Feb. 6, 2013AdvantageSim MD versions 7.4 through 7.6…Class IIIt was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view…
Dec. 26, 2012GE Healthcare…Class IIGE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with…
Oct. 31, 2012GE Healthcare…Class IIGE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient…
Oct. 31, 2012GE Discovery NM/CT670…Class IIGE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery…
Oct. 31, 2012GE Healthcare innova 3100… and 2 more productsClass IIIt was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ…
Oct. 31, 2012GE Seno Advantage 1.x…Class IIGE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno…
Sept. 19, 2012GE Healthcare…Class IIGE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a…
Aug. 22, 2012GE Healthcare Advantage Workstations…Class IIGE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version…
July 25, 2012GE Healthcare…Class IIGE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed /…
July 25, 2012GE Healthcare Optima Mobile X-ray System…Class IIGE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related…
June 27, 2012GE Healthcare…Class IGE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of…
May 4, 2012GE Healthcare…GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it…
March 19, 2012GE Healthcare Innova X-ray Imaging Systems…It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and…
Feb. 23, 2012GE Healthcare…GE Healthcare has become aware of a potential safety issue where an image from a different patient, or an image from the current patient with title…
Feb. 8, 2012GE Healthcare Signa…GE Healthcare has become aware of missing labels on the alignment lasers.
Jan. 21, 2012GE LOGIQ P6 Ultrasound System…GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic…
Jan. 11, 2012GE Healthcare Definium 8000… and 1 more productGE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and…
Jan. 11, 2012GE Healthcare AW Server version 2.0 with release 2.0…2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also…
Nov. 22, 2011Rapid Strand Rx…There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
Oct. 28, 2011GE Healthcare…A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is…
Oct. 26, 2011GE Healthcare…GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause…
Sept. 14, 2011Datex-Ohmeda Trusat Pulse Oximeter And Accessories…The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient…
Sept. 1, 2011GE Healthcare… and 2 more productsGE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo…
Aug. 25, 2011GE Healthcare…GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option…
Aug. 12, 2011GE Healthcare…GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This…
July 21, 2011GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT systemGE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery…
May 19, 2011BrightSpeed Excel Select…GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain…
April 8, 2011GE Healthcare… and 1 more productGE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient…
March 3, 2011GE Healthcare…GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored…
March 2, 2011GE ADVANTAGE SIM MD versions 5.x…GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or…
Feb. 15, 2011Xeleris Processing and Review Workstation 1.0…GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images…
Dec. 3, 2010Xeleris (1.0…GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris…
Nov. 26, 2010GE Seno Advantage 1.x… and 1 more productThe measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography…
Nov. 24, 2010Signa Excite" 1.5 T Magnetic Resonance Systems…Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D…
Nov. 19, 2010Signa OpenSpeed… and 1 more productIf the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
Nov. 15, 2010GE LightSpeed VCT Scanner System… and 1 more productGE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT…
Nov. 15, 2010Power supply boards on Dash 3000…The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient…
Aug. 19, 2010Innova 2000…A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance…
Aug. 12, 2010Datex-Ohmeda Network And Icentral '05…The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring…
June 22, 2010Datex-Ohmeda Trusat Pulse Oximeter And Accessories…GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards. It…
June 11, 2010GE Healthcare…GE Healthcare has become aware of a safety issue associated with the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue includes the…
June 2, 2010GE Healthcare…GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient…
May 26, 2010GE Healthcare… and 2 more productsA potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When…
May 11, 2010GE… and 1 more productUnanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the…
Sept. 25, 2009Definium 5000 X-ray System…A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial…
June 23, 2009GE Datex-Ohmeda Aisys… and 1 more productUnintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown…
April 6, 2009GE Healthcare…GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination…
Jan. 5, 2009GE Healthcare Solar 8000M System…A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been…
Nov. 21, 2008Giraffe OmniBed…Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
Nov. 5, 2008GE Healthcare…Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server could cause excessive CIC Pro memory…
Oct. 27, 2008Monitor suspensions used with Advantx Legacy…GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may…
Sept. 26, 2008GE Stereotaxy Positioner… and 1 more productGE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is…
Sept. 21, 2008GE Innova 3100 / 3100 IQ… and 5 more productsGE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova…
Sept. 20, 2008Innova 2000… and 3 more productsThe charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
Sept. 20, 2008Advantage Workstation version 4.2P…GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the…
Sept. 19, 2008GE Precision MPi… and 2 more productsThe Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray…
Sept. 19, 2008GE Precision 500D… and 1 more productGE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for…
Sept. 11, 2008Panda iRes and Giraffe Infant Warmers…Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
Sept. 5, 2008DST-XL Model 1002375 is a multi-head…GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient…
June 24, 2008S/5 iCentral…Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.
June 10, 2008GE Healthcare Proteus XR/a Radiographic X-ray System…The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.
Nov. 28, 2007GE Healthcare Advantage Workstations…Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is…
Nov. 8, 2007Sunisa Flexi-DT Table…Design Problems Including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop…
Nov. 7, 2007Signa MFO/I Magnetic Resonance System…Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
Oct. 20, 2006GE ApexPro CH Telemetry System…When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or…
July 12, 2006Fresh Gas Control (A-FGC1) Unit…There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in…
May 9, 2006Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or…
Jan. 24, 2006GE Millennium Systems: MC… and 2 more productsIn certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange…
How we match: a recall is listed here when the agency names GE Healthcare as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.
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