FDA · Medical device recall

GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a… and 2 more products

Feb. 18, 2011

Date posted by the FDA: Feb. 18, 2011
Status: Terminated
Filed by: GE Healthcare, LLC
Distribution pattern: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.

3 products in this recall

GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scanner…

Product: GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.
Reason: GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the g
Quantity: 25
Codes and lots: 00000XRMBB0092 00000XRMBB0093 00000XRMBB0098 00000XRMBB0102 00000XRMBB0103 00000XRMBB0106 00000XRMBB0108 00000XRMBB0113 00000XRMBB0115 00000XRMBB0117 00000XRMBB0128 00000XRMBB0134 00000XRMBB0112 00000XRMBB0107 00000XRMBB0076 00000XRMBB0061 00000XRMBB0116 00000XRMBB0077 00000XRMBB0097 00000XRMBB0062 00000XRMBB0130 00000XRMBB0118 00000XRMBB0124 00000XRMBB0095 00000XRMBB0105
Recall started: Nov. 18, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
Recall number: Z-1375-2011

GE Healthcare Discovery MR450 1.5T…

Product: GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Reason: GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the grad
Quantity: 11
Codes and lots: 00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125
Recall started: Nov. 18, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
Recall number: Z-1376-2011

GE Healthcare…

Product: GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.
Reason: GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnel's safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the gra
Quantity: 68
Codes and lots: 00000000HG0010 00000000HG0015 00000000HG0016 00000000HG0017 00000000HG0019 00000000HG0020 00000000HG0022 00000000HG0023 00000000HG0024 00000000HG0025 00000000HG0028 00000000HG0030 00000000HG0034 00000000HG0038 00000000HG0039 00000000515M27 00000000610M26 00000000650M22 00000000678M23 00000000679M21 00000000703M29 00000000731M20 00000000763M23 00000000764M21 00000000776M25 00000000778M21 00000000813M26 00000000814M24 00000000840M29 00000000862M23 00000000889M26 00000000911M28 00000000927M24 00000000933M22 00000000990M22 00000000994M24 00000001009M20 00000001012M24 00000001057M29 00000001059M25 00000001060M23 00000000931M26 00000000929M20 00000000991M20 00000000AANW81 00000000HG0031 00000000HG0006 00000000HG0027 00000000922M25 00000000HG0009 00000000HG0026 00000000HG0029 00000000HG0035 00000000HG0040 00000000611M24 00000000762M25 00000000809M24 00000000811M20 00000000923M23 00000000934M20 00000000992M28 00000001006M26 00000000993M26 00000000HG0032 00000000810M22 00000000863M21 00000000877M21 00000000928M22
Recall started: Nov. 18, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
Recall number: Z-1377-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1375-2011, Z-1376-2011, Z-1377-2011. The agency record governs; check it and the company before acting.

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