CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Lumbar Extension Machine for Physical Therapy recalled by MedX Holdings
MedX Holdings is recalling Lumbar Extension Machine for Physical Therapy, distributed nationwide in the US. The recall was initiated on 3 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0935-2015
- FDA event ID
- 69422
- Recalling firm
- MedX Holdings, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2013
- FDA classified
- 7 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2013 | Recall initiated by company | |
| 7 Jan 2015 | Classified by FDA | +400 days |
| 14 Jan 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Product as listed by the FDA
Lumbar Extension Machine for Physical Therapy
Where it was distributed
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Questions about this recall
Is Lumbar Extension Machine for Physical Therapy recalled?
Yes. MedX Holdings recalled Lumbar Extension Machine for Physical Therapy on 3 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0935-2015.
Why was it recalled?
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Which lots are affected?
Serial Numbers: 01531280, 01531279, 01531278, 01531284, 01531283, 01531282, 01531281, 01531288, 01531287
Where was it sold?
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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