Recall Z-0161-2009 ยท FQO Table, Operating-Room, Ac-Powered
MAQUET Inc.
Accessory Head Rest for Alphastar Operating Tables
| Date | Oct 16, 2008 (initiated Sep 26, 2008) |
| Status | Terminated |
| Reason | During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever. |
| Root cause | Other |
| Action | Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed |
| Quantity | 88 units in US; 1884 units worldwide |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.