Recall Z-0196-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
| Date | Oct 30, 2015 (initiated Sep 23, 2015) |
| Status | Terminated |
| Reason | GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between the MR and surgical tables. |
| Root cause | Process control |
| Action | GE sent an "Urgent Medical Device Correction" letter dated September 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You may continue to use the table. Monitor for any issues in releasing the table. If you see this issue, contact a GE Field Engineer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS) |
| Distribution | Worldwide Distribution - US Distribution including the states of : CA, CO, FL, IL, MI, OH, TX and WI., and to the countries of : AUSTRIA, BRAZIL, FRANCE, GERMANY, JAPAN, POLAND and TURKEY. UPDATE 11-4-2015: Additional states: AZ, MN. Additional countries: Canada, China, Czech Republic, South A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043262 | GE SIGNA EXCITE MR SURGICAL OPTION GE Healthcare, Jan 12, 2005 |