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GE Medical Systems, LLC recalls MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Recalled November 11, 2015 · FDA recall Z-0196-2016 · GE Medical Systems
Hazard
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. · FDA Class II
Units
23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS)
Sold at
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
Description
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.
Product
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →