MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
FDA Recall Z-0196-2016 · Posted 2015-10-30
Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-09-23
Date Terminated2016-03-28
Product Quantity23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS)
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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 Africa, and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.