• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall OPERON Hand Controls for Operon D750, D752, D760, D820 and D850

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
OPERON Hand Controls for Operon D750, D752, D760, D820 and D850
see related information
Date Posted June 06, 2013
Recall Status1 Open
Recall Number Z-1488-2013
Recall Event ID 65062
Product Classification Table, Operating-Room, Electrical - Product Code GDC
Product Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Code Information The hand controls are neither serialized nor lot coded.
Recalling Firm/
Manufacturer
Berchtold Corp.
1950 Hanahan Rd
N Charleston, South Carolina 29406-4878
For Additional Information Contact Chris Mannarino
843-569-6100 Ext. 233
Manufacturer Reason
for Recall
The firm received complaints for unintended movements.
FDA Determined
Cause 2
DESIGN: Device Design
Action Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133.
Quantity in Commerce 3763
Distribution Nationwide Distribution
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.
-
-