Events

Recall of Device Recall Philips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    26514
  • Event Risk Class
    Class 2
  • Event Number
    Z-1125-03
  • Event Initiated Date
    2003-06-27
  • Event Date Posted
    2003-08-12
  • 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=27814
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    If dicom fields for body part, description or accession number are changed, change won't update on the easyweb client or hospital systems.
  • Action
    On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.

Device

Device Recall Philips
  • Model / Serial
    The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to 23 hospitals and medical centers throughout the US.
  • Product Description
    Easy Access || Software releases 1.1, 5.2, 6.2 & 7.2
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA