FDANovember 16, 2017device
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
What to do
FDA enforcement status: Terminated
Brands named
getinge us salesgetingegetinge us
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B02024-10-03
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