Reported May 30, 2018 · Terminated
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the…
Getinge US Sales LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GETINGE US SALES LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient
- Part Numbers
ARD567801093ARD567801094
- Lot codes and dates
- Serial Nos.
667 of 667 codes
ON000104ON000104ON000108ON000108ON000300ON000302ON002984ON002986ON002990ON003002ON003003ON005382ON005383ON005432ON005433ON005434ON005435ON007749ON007751ON007762ON007767ON007769ON007770ON007771ON007772ON007773ON007775ON007776ON007777ON007778ON009146ON009147ON009148ON009149ON009150ON009151ON009152ON009153ON009154ON009155ON009156ON009157ON009160ON009162ON009163ON009164ON009165ON009166ON009172ON009173ON009174ON009178ON009215ON009216ON009217ON009218ON009219ON009234ON009237ON009239
- Serial Nos.
- Amount recalled
- 667
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.
This product could cause temporary or reversible health problems — stop using it.
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