Recall Z-0480-2010 ยท FWZ Operating Room Accessories Table Tray
Maquet Inc.
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
| Date | Dec 2, 2009 (initiated Oct 22, 2009) |
| Status | Terminated |
| Reason | Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large. |
| Root cause | Device Design |
| Action | Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative. |
| Quantity | 9 units in US. |
| Distribution | Nationwide Distribution -- USA, including states of SC and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.