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Terminated

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

FDA Recall Z-1927-2018 · Posted 2018-03-05

Recalling FirmGETINGE US SALES LLC
Recall StatusTerminated
Product CodeFSY
Date Initiated2017-11-16
Date Terminated2021-07-21
Product Quantity667

Reason for Recall

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.

Firm Action

Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

U.S. and Gov. accts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEMAlm S.A. · 2004-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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