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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Surgical Table
Distribution
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