MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
FDA device recall Z-0196-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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
- Date initiated
- 2015-09-23
- Date posted
- 2015-10-30
- Date terminated
- 2016-03-28
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE SIGNA EXCITE MR SURGICAL OPTION (K043262) | GE Healthcare | 2005-01-12 |