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U.S. Department of Health and Human Services

Class 2 Device Recall PS200

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  Class 2 Device Recall PS200 see related information
Date Initiated by Firm June 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 07, 2005
Recall Number Z-0985-04
Recall Event ID 29354
Product Classification unknown device name - Product Code DS-22
Product MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.
Code Information Serial numbers 24371, 24372, 24374, 24375, 24376, 24377, 24379, 24380, 24495, 24496, 24497, 24498, 24499, 24500, 24501, 24502, 24503, 24504, 24505, 24506, 24507, 24508, 25560, 25561, 25562, 25564, 25566, 25567, 25568, 25569, 25570S, 25572, 25573, 25574, 25575, 25576, 25577, 25578, 25579, 25580, 25581, 25582, 25583, 25584S, 25585, 25586, 25587, 25588, 25589
Recalling Firm/
Manufacturer
Minxray Inc
3611 Commercial Ave
Northbrook IL 60062-1822
For Additional Information Contact Mr. Keith R. Kretchmer
847-564-0323
Manufacturer 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 Determined
Cause 2
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 49 units
Distribution New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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