The Recall Desk
HighFDA (Devices)·Z-0936-2015·Announced 2015-01-14

MedX Holdings Recalls Cervical Extension Machines Due to Missing Safety Tests

MedX Holdings is recalling four cervical 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 involves a medical device where required safety tests (HiPot, Continuity, load, friction) were not completed, creating a risk of harm (electrical shock or mechanical failure) even though no injuries have been reported.

Plain-English summary

MedX Holdings, Inc. is recalling four units of the Cervical Extension Machine 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 specific devices during the manufacturing process.

The affected units are identified by serial numbers 02511166, 02511167, 02511171, and 02511170. 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 how to return or dispose of the units.

The recalled product

Product
Cervical Extension Machine for Physical Therapy
Manufacturer
MedX Holdings, Inc.
Category
Medical Device — Physical Therapy Equipment
Hazard
Affected units
4

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 (4)

  • Serial Numbers: 02511166
  • 02511167
  • 02511171
  • 02511170.

Distribution

Distributed in 4 states:

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

Same manufacturer · MedX Holdings, Inc.

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