Recall Z-1927-2018 ยท FSY Light, Surgical, Ceiling Mounted
GETINGE US SALES LLC
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
| Date | Mar 5, 2018 (initiated Nov 16, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017. |
| Quantity | 667 |
| Distribution | U.S. and Gov. accts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM Alm S.A., May 21, 2004 |