Minxray Inc MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.
Brand
Minxray Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Minxray Inc is recalling MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenu due to The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, FL, IL, MA, MN, NV, NY, OH
Page updated: Jan 10, 2026