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U.S. Department of Health and Human Services

Class 2 Device Recall PM200R40 and PW200R40

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 Class 2 Device Recall PM200R40 and PW200R40see related information
Date Initiated by FirmJune 29, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on February 07, 2005
Recall NumberZ-0986-04
Recall Event ID 29354
Product Classification unknown device name - Product Code DS-21
ProductMinXray 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.
Code Information 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
Recalling Firm/
Manufacturer		 Minxray Inc
3611 Commercial Ave
Northbrook IL 60062-1822
For Additional Information ContactMr. 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
ActionMinXray 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 Commerce56 units
DistributionNew 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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