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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Magnus Carbonfibre table top

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 Class 2 Recall
Maquet Magnus Carbonfibre table top
see related information
Date Posted May 23, 2011
Recall Status1 Terminated on August 21, 2013
Recall Number Z-2238-2011
Recall Event ID 58789
Product Classification Table, Radiologic - Product Code KXJ
Product Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
Code Information Article 1180.16F0, serial number 00004 Article 1180.16F2, serial number 00001 and 00002
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan Mandy
201-995-8968
Manufacturer Reason
for Recall
Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.
FDA Determined
Cause 2
DESIGN: Device Design
Action Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected "MAGNUS 1180.16F0 carbon-fibre table tops." The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred. If you have additional questions, please contact yur local MAQUET Customer Service at 1-888-627-8383.
Quantity in Commerce 3
Distribution LA, MO, VA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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