Z-0986-04

MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray...

Name: Z-0986-04 MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray...
Creator: Minxray Inc
Published: 2004-06-29
License: https://open.fda.gov/license/

Minxray Inc / initiated 2004-06-29 / Terminated

FDA source

Minxray Inc began a recall of MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois... on 2004-06-29. The reason FDA records is "The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0986-04
Status: Terminated
Initiated: 2004-06-29
Posted: 2004-07-20
Terminated: 2005-02-07
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.
Product code: DS-21
Reason for recall: The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
FDA 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 in commerce: 56 units
Distribution: New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.
Product codes and lots: 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

Product code DS-21

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)