Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ALM XTEN Surgical Light intended to provide visible illumination for Recalled by GETINGE US SALES LLC Due to Getinge has received complaints concerning the X TEN...

Date: November 16, 2017
Company: GETINGE US SALES LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GETINGE US SALES LLC directly.

Affected 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

Quantity: 667

Why Was This 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.

Where Was This Sold?

U.S. and Gov. accts.

About GETINGE US SALES LLC

GETINGE US SALES LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report