Device product
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Z-1488-2013
Product summary
- Firm
- Berchtold Corp.
- Event
- Event 65062
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3763
- Official record key
device-enforcement:Z-1488-2013
Official wording
Reason: The firm received complaints for unintended movements.
Code information: The hand controls are neither serialized nor lot coded.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The firm received complaints for unintended movements.