Device product
Cervical Extension Machine for Physical Therapy
Z-0936-2015
Product summary
- Event
- Event 69422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0936-2015
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: 02511166, 02511167, 02511171, 02511170.
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.