Events

Recall of Device Recall Philips EasyVision MM workstation with software

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

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
    52108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0412-2011
  • Event Initiated Date
    2009-01-30
  • Event Date Posted
    2010-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82106
  • 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
    Review by firm of philips easyvision mm workstations found that to assure compliance with 21 cfr 900.12(c)(5) corrected software was needed so that all sites are in compliance.
  • Action
    Philips Medical Systems North America Co. sent an URGENT-Field Safety Notice dated January 30, 2009, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised to ascertain the quality of a hard or soft copy explicity before further distribution to make sure that no part of the tissue is covered by image identification information. Philips will issue the Field Change Order (FCO) 83000129 and release a level on EasyVision MM R10.2 L6 and EasyVision MM R11.1 L3 to resolve the issue. Customers could contact Philips Healthcare Call Center at 1-800-722-9377, #2, #3 and Reference FCO 83000129 for any questions.

Device

Device Recall Philips EasyVision MM workstation with software
  • Model / Serial
    Site Numbers:  50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX
  • Product Description
    Philips EasyVision MM workstation with software R10.2 and R11.1 || The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA