ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the pa
FDA device recall Z-1927-2018 · posted 2018-03-05 · Terminated
Recall details
- Recalling firm
- GETINGE US SALES LLC
- 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.
- Action taken
- Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 667
- Distribution
- U.S. and Gov. accts.
- Date initiated
- 2017-11-16
- Date posted
- 2018-03-05
- Date terminated
- 2021-07-21
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALM X'TEN (X10) SURGICAL LIGHT SYSTEM (K040735) | Alm S.A. | 2004-05-21 |