Z-0935-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2015
- Initiation Date
- December 3, 2013
- Termination Date
- September 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
Lumbar Extension Machine for Physical Therapy
Reason for Recall
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Distribution Pattern
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Code Information
Serial Numbers: 01531280, 01531279, 01531278, 01531284, 01531283, 01531282, 01531281, 01531288, 01531287