Recall Z-0188-2009 ยท FQO Table, Operating-Room, Ac-Powered
MAQUET Inc.
Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
| Date | Nov 5, 2008 (initiated Sep 16, 2008) |
| Status | Terminated |
| Reason | Table tilts: The Alphastar Surgical Table piston rod head may break and cause a full inclination of the table top during Trendelenberg positioning if there is insufficient lubrication. |
| Root cause | Equipment maintenance |
| Action | Maquet sent Recall Notification letters to all customers on September 16, 2008 by Federal Express. Letters inform customers of the potential problem with the Alphastar tables, a description of the failure and hazards involved. Hospitals are asked to confirm whether yearly maintenance by an authorized technician have been performed. If preventive maintenance has not been performed, customers are requested to contact their Maquet Service rep. A Customer Service Response form is included and customers are to complete if to acknowledge whether of not the facility is still in possession of an af |
| Quantity | 141 in US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.