| Class 2 Device Recall PS200 | |
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
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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
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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. |
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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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