GETINGE US SALES LLC recalls ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the p…

Recall date

November 16, 2017

Source

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

Recall number

Z-1927-2018

FDA classification

Class II

Brand / firm

GETINGE US SALES LLC

Sold / distributed

U.S. and Gov. accts.

Why it was recalled

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.

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

What was recalled

ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094