Recall Z-2527-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa Excite MR system with Surgical Option is indicated for use as a diagnostic imaging de
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare notified customers on about 03/30/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter informed customers that the MR Surgical Suited System could still remain in use, it referred them to the GE MR Surgical Suite Operator's Manual for detailed descriptions of the various safety interlocks and operating mechanisms, encouraged users to monitor for any issues releasing the transfer board from the GE MR Surgical Table, and instructed users to test the patient transfer features as part of a quality check prior to each use. The letter also informed customers that a GE Healt |
| Quantity | 54 units total |
| Distribution | US Nationwide distribution to AZ, CA, CO, FL, IL, KS, MI, MN, NY, OH, PA, TX, UT, VA, WI. Worldwide distribution to Austria, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, South Africa, Turkey, Turkey, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC, Jun 17, 2004 |