MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illin
FDA device recall Z-0985-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Minxray Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DS-22
- Quantity affected
- 49 units
- Distribution
- New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.
- Date initiated
- 2004-06-29
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-07
- Location
- Northbrook, IL
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