Events

Recall of Device Recall PS200

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Minxray Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29354
  • Event Risk Class
    Class 2
  • Event Number
    Z-0985-04
  • Event Initiated Date
    2004-06-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33586
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code DS-22
  • Reason
    The x-ray units are defective under 21 cfr 1020.30(h) in that the user manual had missing or inadequate information.
  • 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.

Device

Device Recall PS200
  • Model / Serial
    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
  • Distribution
    New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.
  • Product Description
    MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.
  • Manufacturer
    Minxray Inc

Manufacturer

Minxray Inc
  • Manufacturer Address
    Minxray Inc, 3611 Commercial Ave, Northbrook IL 60062-1822
  • Source
    USFDA