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U.S. Department of Health and Human Services

Class 2 Device Recall Cmax 110v Surgical Table Hand Control

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 Class 2 Recall
Cmax 110v Surgical Table Hand Control
see related information
Date Posted July 21, 2009
Recall Status1 Open
Recall Number Z-1599-2009
Recall Event ID 52172
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories. Tabletop positioning and articulations are controlled via the hand control.
Code Information Model Number(s): 2182625; Serial Numbers: AC0001 to AC0221.
Recalling Firm/
Manufacturer
Steris Corp
5960 Heisley Rd
Mentor, Ohio 44060
For Additional Information Contact Barbara E. Rich
440-392-7318
Manufacturer Reason
for Recall
A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out c
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Steris Corp. issued an "Urgent Product Correction" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805. For further questions, contact Steris at 1-800-548-4873 extension 27318.
Quantity in Commerce 217 Units
Distribution Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.
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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