Events

Recall of Diagnost 97

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    27013
  • Event Risk Class
    Class 2
  • Event Number
    Z-1213-03
  • Event Initiated Date
    2003-08-10
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28996
  • 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
    Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
  • Reason
    Potential for table to move by itself.
  • Action
    The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade.

Device

Diagnost 97

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA