Events

Recall of URO PRO Plus Digital Urology Imaging System

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
    27677
  • Event Risk Class
    Class 2
  • Event Number
    Z-0162-04
  • Event Initiated Date
    2003-08-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30326
  • 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
    System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    X-ray tube arm and collimator fell and fractured patient's ribs.
  • Action
    An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.

Device

URO PRO Plus Digital Urology Imaging System
  • Model / Serial
    Serial Numbers:  UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NM, NV, WA, CA.
  • Product Description
    URO PRO Plus Digital Urology Imaging System
  • Manufacturer
    Medstone International Inc

Manufacturer

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