Events

Recall of Device Recall OmniDiagnost

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
    26837
  • Event Risk Class
    Class 2
  • Event Number
    Z-0874-03
  • Event Initiated Date
    2003-07-17
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28537
  • 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
    Labeling of push button caps located on the control panel may not clearly identify the applied source to image distance (sid).
  • Action
    On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.

Device

Device Recall OmniDiagnost
  • Model / Serial
    OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161;  The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
  • Product Classification
    Radiology Devices
  • Distribution
    The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
  • Product Description
    OmniDiagnost System
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

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