Recall Z-0857-2022 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
| Date | Apr 4, 2022 (initiated Feb 18, 2022) |
| Status | Open, Classified |
| Reason | There is potential for the images to be flipped left to right. |
| Root cause | Device Design |
| Action | This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions a |
| Quantity | 10 units |
| Distribution | Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Po |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM GE Medical Systems, Aug 3, 2001 |