Recall Z-0196-2016— GE Medical Systems, LLC

Name: FDA recall Z-0196-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-23

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-09-23, terminated 2016-03-28. It names one FDA 510(k) clearance: K043262. Product: MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS. 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Terminated: 2016-03-28
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K043262 — GE SIGNA EXCITE MR SURGICAL OPTIONGE Healthcare·cleared 2005-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.