Cervical Extension Machine for Physical Therapy
FDA device recall Z-0936-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- MedX Holdings, Inc.
- Reason for recall
- Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
- Action taken
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- IKK
- Quantity affected
- 4
- Distribution
- Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
- Date initiated
- 2013-12-03
- Date posted
- 2015-01-07
- Date terminated
- 2016-09-29
- Location
- Ocala, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (K896553) | Medx Corp. | 1990-01-02 |