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U.S. Department of Health and Human Services

Class 2 Device Recall Connection Bracket

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  Class 2 Device Recall Connection Bracket see related information
Date Initiated by Firm October 22, 2009
Date Posted December 02, 2009
Recall Status1 Terminated 3 on May 18, 2010
Recall Number Z-0480-2010
Recall Event ID 53612
Product Classification Operating-Room Table Accessories - Product Code FWZ
Product Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0.

An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
Code Information No serial or lot numbers, just a catalogue number.
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact James Molloy
973-709-7227
Manufacturer 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 2		 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 in Commerce 9 units in US.
Distribution Nationwide Distribution -- USA, including states of SC and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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