Class 2 Device Recall ALM X TEN

• Date Initiated by Firm: November 16, 2017
• Date Posted: March 05, 2018
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-1927-2018
• Recall Event ID: 79340
• 510(K)Number: K040735
• Product Classification: Surgical Lights - Product Code FSY
• 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
• Code Information: Serial Nos. 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ON089586 ON089587 ON089593 ON089594 ON089594 ON089595 ON090484 ON090518 ON090521 ON090522 ON090559 ON090561 ON090562 ON091160 ON091164 ON091165 ON091167 ON091168 ON091169 ON091171 ON091172 ON091173 ON091174 ON091175 ON091176 ON091178 ON093627 ON093628 ON093629 ON093630 ON093636 ON093637 ON093638 ON093642 ON093645 ON093646 ON093649 ON093650 ON093653 ON093998 ON093999 ON094000 ON094001 ON094002 ON094003 ON094004 ON094005 ON094006 ON094007 ON094008 ON094009 ON094011 ON094026 ON094029 ON096315 ON096316 ON096317 ON096322 ON096327 ON096329 ON096330 ON096331 ON096332 ON096334 ON096345 ON096346 ON096379 ON096380 ON096381 ON096411 ON096412 ON096413 ON096560 ON096561 ON096562 ON096563 ON096564 ON096565 ON096566 ON096567 ON096568 ON096569 ON096572 ON096574 ON096575 ON096576 ON096577 ON096578 ON096579 ON098347 ON098348 ON098349 ON098350 ON098351 ON098352 ON098353 ON098354 ON098355 ON098356 ON098357 ON098358 ON098359 ON098360 ON098361 ON098378 ON098380 ON098381 ON098384 ON098385 ON098387 ON098390 ON098391
• Recalling Firm/ Manufacturer: GETINGE US SALES LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Barb Smith; 585-214-6049
• Manufacturer 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.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017.
• Quantity in Commerce: 667
• Distribution: U.S. and Gov. accts.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FSY and Original Applicant = ALM S.A.