FDA Device recall Z-1927-2018

ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient

FDA Device
Class II
terminated
Published 2018-05-30

On 2018-05-30 the FDA classified a Class II recall of ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient by Getinge Us Sales, citing 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 crackin….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1927-2018
Classification	Class II
Status	terminated
Initiated	2017-11-16
Published	2018-05-30
Last updated	2026-09-13 11:54 UTC
Company	Getinge Us Sales
Distribution	n/a

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.

Identifiers

code_info	Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON00300… Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON003003 ON005382 ON005383 ON005432 ON005433 ON005434 ON005435 ON007749 ON007751 ON007762 ON007767 ON007769 ON007770 ON007771 ON007772 ON007773 ON007775 ON007776 ON007777 ON007778 ON009146 ON009147 ON009148 ON009149 ON009150 ON009151 ON009152 ON009153 ON009154 ON009155 ON009156 ON009157 ON009160 ON009162 ON009163 ON009164 ON009165 ON009166 ON009172 ON009173 ON009174 ON009178 ON009215 ON009216 ON009217 ON009218 ON009219 ON009234 ON009237 ON009239 ON009240 ON012141 ON012142 ON012143 ON012144 ON012146 ON012155 ON012156 ON012158 ON013719 ON013720 ON013721 ON013722 ON015435 ON015436 ON015437 ON015438 ON015439 ON015440 ON015441 ON015442 ON015459 ON015460 ON015461 ON015462 ON015463 ON015464 ON015465 ON015466 ON015467 ON015468 ON015469 ON015470 ON015471 ON015472 ON015473 ON015474 ON015481 ON015484

code_info

Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON00300…

Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON003003 ON005382 ON005383 ON005432 ON005433 ON005434 ON005435 ON007749 ON007751 ON007762 ON007767 ON007769 ON007770 ON007771 ON007772 ON007773 ON007775 ON007776 ON007777 ON007778 ON009146 ON009147 ON009148 ON009149 ON009150 ON009151 ON009152 ON009153 ON009154 ON009155 ON009156 ON009157 ON009160 ON009162 ON009163 ON009164 ON009165 ON009166 ON009172 ON009173 ON009174 ON009178 ON009215 ON009216 ON009217 ON009218 ON009219 ON009234 ON009237 ON009239 ON009240 ON012141 ON012142 ON012143 ON012144 ON012146 ON012155 ON012156 ON012158 ON013719 ON013720 ON013721 ON013722 ON015435 ON015436 ON015437 ON015438 ON015439 ON015440 ON015441 ON015442 ON015459 ON015460 ON015461 ON015462 ON015463 ON015464 ON015465 ON015466 ON015467 ON015468 ON015469 ON015470 ON015471 ON015472 ON015473 ON015474 ON015481 ON015484

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.