Recall Z-0480-2010
Maquet Inc. · initiated October 22, 2009
Product
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
Codes / lots: No serial or lot numbers, just a catalogue number.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0480-2010
- Initiated
- October 22, 2009
- Posted by FDA
- December 2, 2009
- Terminated
- May 18, 2010
- Product code
- FWZ – Operating Room Accessories Table Tray
- Quantity
- 9 units in US.
- Distribution
- Nationwide Distribution -- USA, including states of SC and PA.
- Recalling firm
- Maquet Inc., Wayne, NJ