ALM XTEN Surgical Light intended to provide visible illumination for… — Class II medical device recall Z-1927-2018
Terminated recall by GETINGE US SALES LLC, reported 2018-05-30. Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing li
| Recall number | Z-1927-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, Wayne, NJ, United States |
| Recall initiated | 2017-11-16 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2021-07-21 |
| Quantity | 667 |
| Reason classes | packaging |
| Serial numbers | ON000104, ON000108, ON000300, ON000302, ON002984, ON002986, ON002990, ON003002, ON003003, ON005382, ON005383, ON005432, ON005433, ON005434, ON005435, ON007749, ON007751, ON007762, ON007767, ON007769, ON007770, ON007771, ON007772, ON007773, ON007775 and 475 more |
| Model numbers | ARD567801093, ARD567801094 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.