FDA-Device2018-05-30Class II
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
GETINGE US SALES LLC
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.
Sold states
U.S. and Gov. accts.
Affected count
667
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2018Don't want to check this manually?
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