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Terminated

MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.

FDA Recall Z-0985-04 · Posted 2004-07-20

Recalling FirmMinxray Inc
Recall StatusTerminated
Product CodeDS-22
Date Initiated2004-06-29
Date Terminated2005-02-07
Product Quantity49 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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