FDA Medical Device Recalls (openFDA)
MedX Holdings, Inc.: Cervical Extension Machine for Physical Therapy
- Recall number
- Z-0936-2015
- Recalling firm
- MedX Holdings, Inc.
- Product
- Cervical Extension Machine for Physical Therapy
- Status
- Terminated
- Initiated
- 2013-12-03
- Posted
- 2015-01-07
- Terminated
- 2016-09-29
- 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.
- Lot, serial or model codes
- Serial Numbers: 02511166, 02511167, 02511171, 02511170.
- 510(k) numbers
- ["K896553"]
- PMA numbers
- not on file
- Product code
- IKK
- Firm FEI
- 1051095
- Firm city
- Ocala
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28