Recall Z-0986-04 ยท DS-
Minxray Inc
MinXray 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.
| Date | Jul 20, 2004 (initiated Jun 29, 2004) |
| Status | Terminated |
| Reason | The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information. |
| Root cause | 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 | 56 units |
| Distribution | New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.