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GETINGE US SALES LLC recalls ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the pa
Recalled May 30, 2018 · FDA recall Z-1927-2018 · GETINGE US SALES
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. · FDA Class II
Units
667
Sold at
U.S. and Gov. accts.
Description
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.
Product
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
Manufacturer(s)
GETINGE US SALES LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →