Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
FDA Recall Z-0480-2010 · Posted 2009-12-02
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Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeFWZ
Date Initiated2009-10-22
Date Terminated2010-05-18
Product Quantity9 units in US.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution -- USA, including states of SC and PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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