Events

Recall of Device Recall MagicView 1000U, version VE40A

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    25928
  • Event Risk Class
    Class 2
  • Event Number
    Z-1029-03
  • Event Initiated Date
    2003-02-28
  • Event Date Posted
    2003-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26730
  • 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
  • Reason
    Software issue. new examinations may not be saved properly and the examination may be lost.
  • Action
    The recalling firm has issued a letter to their field service representative dated 2/28/02. The letter is entitled Safety Modification CN002/03/S which instructs the recalling firm's service engineers to visit each affected site and correct the software problem. A set of instructions were sent with the letter.

Device

Device Recall MagicView 1000U, version VE40A
  • Model / Serial
    Part number 7502003
  • Distribution
    The product was shipped to medical facilities in AL, CA, CO, FL, NE, IL, IN, MI, MN, NJ, NY, OH, PA, TN, and VA.
  • Product Description
    Magic View 1000U, version VE40A. Digital Image Communication System
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Parkway, Malvern PA 19355
  • Source
    USFDA