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Class 2 Device Recall OPERON Hand Controls for Operon D750, D752, D760, D820 and D850 |
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Date Initiated by Firm |
March 12, 2013 |
Date Posted |
June 06, 2013 |
Recall Status1 |
Terminated 3 on May 08, 2017 |
Recall Number |
Z-1488-2013 |
Recall Event ID |
65062 |
Product Classification |
Table, operating-room, electrical - Product Code GDC
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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 SC 29406-4878
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For Additional Information Contact |
Chris Mannarino 843-569-6100 Ext. 233
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Manufacturer Reason for Recall |
The firm received complaints for unintended movements.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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