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U.S. Department of Health and Human Services

Class 2 Device Recall Operon

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 Class 2 Recall
Operon
see related information
Date Posted April 27, 2009
Recall Status1 Terminated on June 04, 2009
Recall Number Z-1123-2009
Recall Event ID 51276
Product Classification Table, Operating-Room, Electrical - Product Code GDC
Product Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
Code Information D 850, D750, D 752 and B 810.
Recalling Firm/
Manufacturer
Berchtold Corp.
1950 Hanahan Rd
N Charleston, South Carolina 29406-4878
For Additional Information Contact Heath Hines
800-243-5135 Ext. 263
Manufacturer Reason
for Recall
Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece.
FDA Determined
Cause 2
DESIGN: Device Design
Action An official notification letter dated February 3, 2009 was hand-carried by a local Berchtold Corporation Technical Service representative to each account. The letter indicated that the Berchtold Corporation Service Technician will complete recommended upgrades. Direct questions concerning this recall to your BERCHTOLD Technician Service at 1-800-243-5135 and press the Number 2.
Quantity in Commerce 453 units
Distribution Worldwide Distribution -- US 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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