GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850…

Date

Feb. 5, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.

Reason

GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.

Distribution pattern

Nationwide Distribution including DC and PR, except DE, SD, ND, and VT. OUS: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.

Quantity

40,239 (17,182 units US, 23,147 units OUS).

Codes and lots

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SEW11497537HA M1176021-094955 SEW11497538HA M1176021-094955 SEW11497539HA M1176021-094955 SEW11497540HA M1176021-094955 SEW11497555HA M1176021-094955 SEW11497556HA M1176021-094955 SEW11497557HA M1176021-094955 SEW11497558HA M1176021-094955 SEW11497560HA M1176021-094955 SEW11497581HA M1176021-094955 SEW11497583HA M1176021-094955 SEW11497584HA M1176021-094955 SEW11497585HA M1176021-094955 SEW12049003HA M1176021-100869 SEW12059331HA M1176021-100713 SEW12316595HA M1176021-120906 SEW12316596HA M1176021-120906 SEW12357363HA M1176021-120906 SEW12357365HA M1176021-120906 SEW12357366HA M1176021-120906 SEW12357368HA M1176021-120906 SEW12357485HA M1176021-120906 SEW12357488HA M1176021-120906 SEW12357489HA M1176021-120906 SEW12357490HA M1176021-120906 SEW13068518HA M1176021-094955 SEW13193084HA M1176021-186679 SEW13193101HA M1176021-186640 SEW13193102HA M1176021-186640 SEW13203400HA M1176021-186640 SEW13244941HA M1176021-187302 SED11168563GA 2020913-002 SED12526653GA 2020913-003 SED12526658GA 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SED13169011GA 2020913-002 SED13169012GA 2020913-002 SED13169013GA 2020913-002 SED13169014GA 2020913-002 SED13169045GA 2020913-002 SED13169046GA 2020913-002 SED13169050GA 2020913-002 SED13169055GA 2020913-002 SED13169056GA 2020913-002 SED13169057GA 2020913-002 SED13169059GA 2020913-002 SED13169060GA 2020913-002 SED13169061GA 2020913-002 SED13169062GA 2020913-002 SED13169063GA 2020913-002 SED13169064GA 2020913-002 SED13169070GA 2020913-002 SED13169087GA 2020913-002 SED13169093GA 2020913-002 SED13169116GA 2020913-002 SED13169120GA 2020913-002 SED13169125GA 2020913-002 SED13169126GA 2020913-002 SED13169127GA 2020913-002 SED13169129GA 2020913-002 SED13169131GA 2020913-002 SED13169132GA 2020913-002 SED13169135GA 2020913-002 SED13169141GA 2020913-002 SED13179229GA 2020913-002 SED13189379GA 2020913-002 SED13189380GA 2020913-002 SED13189470GA 2020913-002 SED13189495GA 2020913-002 SED13189500GA 2020913-002 SED13189502GA 2020913-002 SED13189504GA 2020913-002 SED13189505GA 2020913-002 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SED13229947GA 2020913-003 SED13229948GA 2020913-003 SED13229949GA 2020913-003 SED13229950GA 2020913-003 SED13229951GA 2020913-003 SED13229952GA 2020913-003 SED13229953GA 2020913-003 SED13229954GA 2020913-003 SED13229955GA 2020913-003 SED13229956GA 2020913-003 SED13230023GA 2020913-002 SED13230024GA 2020913-002 SED13230043GA 2020913-003 SED13239963GA 2020913-003 SED13239964GA 2020913-003 SED13239965GA 2020913-003 SED13239966GA 2020913-003 SED13239967GA 2020913-003 SED13239968GA 2020913-003 SED13239969GA 2020913-003 SED13239970GA 2020913-003 SED13239971GA 2020913-003 SED13239972GA 2020913-003 SED13239974GA 2020913-002 SED13239977GA 2020913-002 SED13270066GA 2020913-003 SED13270113GA 2020913-002 SED13270117GA 2020913-002 SED13270190GA 2020913-002 SED13270211GA 2020913-002 SED13270230GA 2020913-002 SED13280427GA 2020913-002 SED13280428GA 2020913-002 SED13280435GA 2020913-002 SED13280445GA 2020913-002 SED13290458GA 2020913-002 SED09471473GA 2020913-002 SED10021715GA 2020913-002 SED10021720GA 2020913-002 SED10041824GA 2020913-002 SED10112150GA 2020913-002 SED10112155GA 2020913-002 SED10112156GA 2020913-002 SED10112165GA 2020913-002 SED10112173GA 2020913-002 SED10112199GA 2020913-002 SED10122287GA 2020913-002 SED10122288GA 2020913-002 SED10122291GA 2020913-002 SED10122297GA 2020913-002 SED10122314GA 2020913-002 SED10122331GA 2020913-002 SED10122332GA 2020913-002 SED10122334GA 2020913-002 SED10122335GA 2020913-002 SED10132473GA 2020913-002 SED10293123GA 2020913-002 SED10293124GA 2020913-002 SED10303335GA 2020913-002 SED10333640GA 2020913-002 SED11178619GA 2020913-002 PA1793431 2044032-002 PA1793432 2044032-002 PA1793433 2044032-002 PA1793434 2044032-002 PA1793435 2044032-002 PA1793436 2044032-002 PA1793437 2044032-002 PA1793438 2044032-002 PA1793439 2044032-002 PA1793440 2044032-002 PA1793441 2044032-002 PA1793442 2044032-002 PA1793443 2044032-002 PA1793444 2044032-002 PA1793445 2044032-002 PA1793446 2044032-002 PA1793447 2044032-002 PA1793448 2044032-002 PA1793449 2044032-002 PA1793450 2044032-002 PA1838743 2044032-002 PA1838744 2044032-002 PA1838745 2044032-002 PA1838746 2044032-002 PA1838747 2044032-002 PA1838748 2044032-002 PA1838749 2044032-002 PA1838750 2044032-002 PA1838751 2044032-002 PA1838752 2044032-002 PA1838753 2044032-002 PA1838754 2044032-002 PA1838755 2044032-002 PA1838756 2044032-002 PA1838757 2044032-002 PA1838758 2044032-002 PA1838759 2044032-002 PA1964846 2044032-002 PA1964847 2044032-002 PA1964848 2044032-002 PA1964849 2044032-002 PA1964850 2044032-002 PA1964851 2044032-002 PA1964852 2044032-002 PA1964853 2044032-002 PA1964854 2044032-002 SED09340611GA 2020913-003 SED09340616GA 2020913-003 SED09340618GA 2020913-003 SED09340619GA 2020913-003 SED09340620GA 2020913-003 SED09340621GA 2020913-003 SED09340622GA 2020913-003 SED09340629GA 2020913-003 SED09340646GA 2020913-003 SED09340654GA 2020913-003 SED09340655GA 2020913-003 SED09400923GA 2020913-002 SED09400942GA 2020913-002 SED09400944GA 2020913-002 SED09400947GA 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SED10132468GA 2020913-002 SED10142525GA 2020913-002 SED10142532GA 2020913-002 SED10142536GA 2020913-002 SED10142537GA 2020913-002 SED10142555GA 2020913-002 SED10142581GA 2020913-002 SED10142582GA 2020913-002 SED10142587GA 2020913-002 SED10152600GA 2020913-002 SED10152603GA 2020913-002 SED10152606GA 2020913-002 SED10152607GA 2020913-002 SED10152609GA 2020913-002 SED10152610GA 2020913-002 SED10152611GA 2020913-002 SED10152613GA 2020913-002 SED10152614GA 2020913-002 SED10152618GA 2020913-002 SED10152619GA 2020913-002 SED10152621GA 2020913-002 SED10152622GA 2020913-002 SED10152623GA 2020913-002 SED10152624GA 2020913-002 SED10152625GA 2020913-002 SED10152637GA 2020913-002 SED10152650GA 2020913-002 SED10162679GA 2020913-002 SED10162688GA 2020913-002 SED10182702GA 2020913-002 SED10182703GA 2020913-002 SED10182704GA 2020913-002 SED10182705GA 2020913-002 SED10303419GA 2020913-002 SED10303420GA 2020913-002 SED10303440GA 2020913-002 SED10303441GA 2020913-002 SED10303443GA 2020913-002 SED10303444GA 2020913-002 SED10303446GA 2020913-002 SED10303447GA 2020913-002 SED10303449GA 2020913-002 SED10303450GA 2020913-002 SED10303451GA 2020913-002 SED10303452GA 2020913-002 SED10303453GA 2020913-002 SED10303454GA 2020913-002 SED10303455GA 2020913-002 SED10313458GA 2020913-002 SED10313459GA 2020913-002 SED10353742GA 2020913-002 SED10353743GA 2020913-002 SED10464945GA 2020913-002 SED10464949GA 2020913-002 SED10464959GA 2020913-002 SED10464960GA 2020913-002 SED10464961GA 2020913-002 SED10464962GA 2020913-002 SED10464963GA 2020913-002 SED10464964GA 2020913-002 SED10464965GA 2020913-002 SED10464966GA 2020913-002 SED10464967GA 2020913-002 SED10464968GA 2020913-002 SED10464969GA 2020913-002 SED10464971GA 2020913-002 SED10474973GA 2020913-002 SED10474974GA 2020913-002 SED10474975GA 2020913-002 SED10474976GA 2020913-002 SED10474977GA 2020913-002 SED10474978GA 2020913-002 SED10474979GA 2020913-002 SED10474980GA 2020913-002 SED10474981GA 2020913-002 SED10474982GA 2020913-002 SED10474983GA 2020913-002 SED10474984GA 2020913-002 SED10474985GA 2020913-002 SED10474986GA 2020913-002 SED10474987GA 2020913-002 SED10474988GA 2020913-002 SED10474989GA 2020913-002 SED10474990GA 2020913-002 SED10474991GA 2020913-002 SED10474992GA 2020913-002 SED10474993GA 2020913-002 SED10474994GA 2020913-002 SED10474995GA 2020913-002 SED10474996GA 2020913-002 SED10474997GA 2020913-002 SED10474998GA 2020913-002 SED10474999GA 2020913-002 SED10475002GA 2020913-002 SED10475003GA 2020913-002 SED10475004GA 2020913-002 SED10475005GA 2020913-002 SED10475009GA 2020913-002 SED10485114GA 2020913-002 SED10485116GA 2020913-002 SED10505371GA 2020913-002 SED10505373GA 2020913-002 SED10505389GA 2020913-002 SED10505390GA 2020913-002 SED10505416GA 2020913-002 SED10505425GA 2020913-002 SED10505431GA 2020913-002 SED10505447GA 2020913-002 SED10505448GA 2020913-002 SED10505449GA 2020913-002 SED10505472GA 2020913-002 SED10505480GA 2020913-002 SED10505481GA 2020913-002 SED10505488GA 2020913-002 SED10505498GA 2020913-002 SED10505499GA 2020913-002 SED10505510GA 2020913-002…

Recall started

Dec. 27, 2013

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter between December 27, 2013 and June 27, 2013, to all affected customers. The letter described the Safety Issues and Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044 or their local Service Representative. For questions regarding this recall call 800-558-7044.

Recall number

Z-0854-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0854-2014. The agency record governs; check it and the company before acting.