Z-1488-2013 Class II Terminated
FDA device recall Z-1488-2013 was initiated by Berchtold Corp. on March 12, 2013 and is designated Class II. Reason for recall: The firm received complaints for unintended movements. The recall status is terminated (terminated May 8, 2017). Affected quantity: 3763.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- March 12, 2013
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3763
Product Description
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Reason for Recall
The firm received complaints for unintended movements.
Distribution Pattern
Nationwide Distribution
Code Information
The hand controls are neither serialized nor lot coded.