Device product
Lumbar Extension Machine for Physical Therapy
Z-0935-2015
Product summary
- Event
- Event 69422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-0935-2015
Official wording
Reason: Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Code information: Serial Numbers: 01531280, 01531279, 01531278, 01531284, 01531283, 01531282, 01531281, 01531288, 01531287
Distribution pattern: Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Derived failure modes
-
Unknown
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.