FDAAugust 17, 2015device
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical inte...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascular us salesmaquetmaquet cardiovascular
Recall history
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