MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Reported: November 11, 2015 Initiated: September 23, 2015 #Z-0196-2016
Product Description
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units 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 11-4-2015: Additional states: AZ, MN. Additional countries: Canada, China, Czech Republic, South Africa, and United Kingdom
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS. Recalled by GE Medical Systems, LLC. Units affected: 23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0196-2016.
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