Recall Z-1927-2018— GETINGE US SALES LLC

Name: FDA recall Z-1927-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-16

Class II · Terminated

Class II FDA medical device recall by GETINGE US SALES LLC, initiated 2017-11-16, terminated 2021-07-21. It names one FDA 510(k) clearance: K040735. 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. Reason: 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..

Recalling firm: GETINGE US SALES LLC
Classification: Class II
Status: Terminated
Initiated: 2017-11-16
Terminated: 2021-07-21
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K040735 — ALM X'TEN (X10) SURGICAL LIGHT SYSTEMAlm S.A.·cleared 2004-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.