GE Medical Systems, LLC recalls MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS

Recall date

September 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0196-2016

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

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…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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