Events

Recall of Device Recall Medstone STST Mobile xray system used with the STST lithotripter.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medstone International 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
    29909
  • Event Risk Class
    Class 2
  • Event Number
    Z-0884-04
  • Event Initiated Date
    2004-06-11
  • Event Date Posted
    2004-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34757
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Units are defective in that the identification and certification labels were inadequate or missing. the beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required.
  • Action
    Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.

Device

Device Recall Medstone STST Mobile xray system used with the STST lithotripter.

Manufacturer

Medstone International Inc
  • Manufacturer Address
    Medstone International Inc, 100 Columbia 100, Aliso Viejo CA 92656
  • Source
    USFDA