FDA Medical Device Recalls (openFDA)
Berchtold Corp.: Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
- Recall number
- Z-1488-2013
- Recalling firm
- Berchtold Corp.
- Product
- Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
- Status
- Terminated
- Initiated
- 2013-03-12
- Posted
- 2013-06-06
- Terminated
- 2017-05-08
- Reason
- The firm received complaints for unintended movements.
- Root cause
- 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
- 3763
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- The hand controls are neither serialized nor lot coded.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDC
- Firm FEI
- 1220685
- Firm city
- N Charleston
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28