FDA Medical Device Recalls (openFDA)
Minxray Inc: MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.
- Recall number
- Z-0986-04
- Recalling firm
- Minxray Inc
- Product
- MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.
- Status
- Terminated
- Initiated
- 2004-06-29
- Posted
- 2004-07-20
- Terminated
- 2005-02-07
- Reason
- The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
- Root cause
- Other
- Action
- MinXray sent recall letters dated 6/29/04 to their dealer accounts via certified mail, asking them to provide the names and addresses of all end-users to whom the affected models of x-ray units were sold. MinXray will then send addenda to the original user manuals to all identified end-users via certified mail, with a letter instructing them to substitute the new Specifications pages for the original page, and adding the Cooling Curve to the manual.
- Quantity
- 56 units
- Distribution
- New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.
- Lot, serial or model codes
- Model PM200R40: serial numbers 23528M, 23531M, 23533M, 23534M, 23535M, 23536M, 24360M, 24361M, 24363M, 24364M, 24365M, 24368M, 24369M, 25148M, 25149, 25390M, 25391M, 25392M, 25393M, 25394M, 25395M, 25396M, 25397M, 25400M, 25402M, 25403M, 25404M, 25405M, 25406M, 25407M, 25408, 26500M, 26501, 26502, 26503M, 26504M, 26505, 26506, 26508, 26509, 26510, 26511, 26512, 26513M, 26514, 26515, 26516, 26517, 26518, 26519 Model PW200R40, serial numbers 23530, 23538, 24362W, 24367W, 24369W, 25399W
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DS-21
- Firm FEI
- 1418960
- Firm city
- Northbrook
- Firm state
- IL
- 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
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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