Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
This recall has been terminated (originally issued June 6, 2013).
- Company
- Berchtold Corp.
- Recall Initiated
- March 12, 2013
- Posted
- June 6, 2013
- Terminated
- May 8, 2017
- Recall Number
- Z-1488-2013
- Quantity
- 3763
- Firm Location
- Charleston, SC
- Official Source
- View on FDA website ↗
Reason for Recall
The firm received complaints for unintended movements.
Distribution
Nationwide Distribution
Lot / Code Info
The hand controls are neither serialized nor lot coded.
Root Cause
Device Design
Action Taken
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.