Recall Z-0983-2022 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.
| Date | Apr 21, 2022 (initiated Mar 4, 2022) |
| Status | Open, Classified |
| Reason | During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm, GE Healthcare, issued "URGENT MEDICAL DEVICE CORRECTION" letters to U.S. consignees dated 3/4/2022 via FedEx. Letters to OUS consignees began on 3/10/2022 via FedEx. The letters explained the issue, the affected product (all GE Healthcare MR Systems), and informed the consignee the device can continue to be used. Actions to be taken by the customer/user are: 1) If you are planning to de-install your GE Healthcare MR System, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative prior to any activities so that GE Healthcare can provide |
| Quantity | 18,411 systems |
| Distribution | Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211980 | SIGNA Prime Ge Healthcare (Tianjin) Company Limited, Jan 16, 2022 |