Z-0936-2015 Class II Terminated
FDA device recall Z-0936-2015 was initiated by MedX Holdings, Inc. on December 3, 2013 and is designated Class II. Reason for recall: Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. The recall status is terminated (terminated September 29, 2016). Affected quantity: 4.
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
- 4
Product Description
Cervical 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: 02511166, 02511167, 02511171, 02511170.