Recall Z-1488-2013
Berchtold Corp. · initiated March 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Codes / lots: The hand controls are neither serialized nor lot coded.
Reason for recall
The firm received complaints for unintended movements.
FDA-determined 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.
Details
- Recall number
- Z-1488-2013
- Initiated
- March 12, 2013
- Posted by FDA
- June 6, 2013
- Terminated
- May 8, 2017
- Product code
- GDC – Table, Operating-Room, Electrical
- Quantity
- 3763
- Distribution
- Nationwide Distribution
- Recalling firm
- Berchtold Corp., N Charleston, SC