The Recall Desk
HighFDA (Devices)·Z-0196-2016·Announced 2015-11-11

GE Recalls MR Surgical Suite II Tables Due to Transfer Mechanism Issue

GE Medical Systems is recalling MR Surgical Suite II Tables because a defect in the transfer release mechanism may prevent patient transfer between the MR and surgical tables.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the defect may prevent patient transfer, but no injuries or illnesses have been reported.

Plain-English summary

GE Medical Systems, LLC is recalling the MR Surgical Suite II Table, including models M8074SS, M8053SS, M0074SS, and M0001SS. The recall involves 35 units distributed worldwide, with 14 units in the United States and 21 units outside the US.

The recall was initiated because GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. This issue may prevent patient transfer between the MR and surgical tables. The agency has classified this recall as Class II.

Affected units are distributed in the US states of CA, CO, FL, IL, MI, OH, TX, WI, AZ, and MN, as well as in Austria, Brazil, France, Germany, Japan, Poland, Turkey, Canada, China, the Czech Republic, South Africa, and the United Kingdom. Users should contact GE Medical Systems for further instructions regarding the affected equipment.

The recalled product

Product
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS

Distribution

Distributed in 8 states: