MedX Lumbar Extension Machines Recalled for Incomplete Safety Testing
MedX Holdings is recalling nine Lumbar Extension Machines because required safety re-testing was not completed during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
MedX Holdings, Inc. is recalling nine Lumbar Extension Machines for Physical Therapy. The recall was initiated after a review of Device History Records (DHRs) revealed that HiPot, Continuity, load, and friction re-testing was not completed on these devices during the manufacturing process.
The affected units are identified by the following serial numbers: 01531280, 01531279, 01531278, 01531284, 01531283, 01531282, 01531281, 01531288, and 01531287. These devices were distributed worldwide, including in the United States (specifically Missouri, Illinois, Idaho, and Minnesota) and internationally to Germany and South Korea.
Consumers and healthcare facilities should stop using the affected devices immediately and contact MedX Holdings, Inc. for instructions on return or replacement.
The recalled product
- Product
- Lumbar Extension Machine for Physical Therapy
- Manufacturer
- MedX Holdings, Inc.
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Serial Numbers: 01531280
- 01531279
- 01531278
- 01531284
- 01531283
- 01531282
- 01531281
- 01531288
- 01531287
Distribution
Part of a larger recall action
This product is one of 2 recalled by MedX Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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