Recall Z-0936-2015 ยท IKK System, Isokinetic Testing And Evaluation
MedX Holdings, Inc.
Cervical Extension Machine for Physical Therapy
| Date | Jan 7, 2015 (initiated Dec 3, 2013) |
| Status | Terminated |
| Reason | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
| Root cause | Unknown/Undetermined by firm |
| Action | Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field. For questions regarding this recall call 322-351-2005. |
| Quantity | 4 |
| Distribution | Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896553 | MEDX CERVICAL EXTENSION TEST & REHAB MACHINE Medx Corp., Jan 2, 1990 |