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U.S. Department of Health and Human Services

Class 2 Device Recall Cmax Surgical Table

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 Class 2 Recall
Cmax Surgical Table
see related information
Date Posted February 23, 2007
Recall Status1 Terminated on September 11, 2009
Recall Number Z-0554-2007
Recall Event ID 37349
Product Classification Table, Operating-Room, Electrical - Product Code GDC
Product Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450
Code Information Serial Numbers: C429106030 through C436306020
Recalling Firm/
Manufacturer
Steris Corporation
2720 Gunter Park Drive East
Montgomery, Alabama 36109-1410
For Additional Information Contact Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall
A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action A certified letter was sent to all affected consignees on February 6, 2007 notifying them of the issue and informing them of the recall and the replacement of the affected tables with new tables.
Quantity in Commerce 46 tables
Distribution USA and Canada
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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