Events

Recall of Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare Informatics, 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
    50751
  • Event Risk Class
    Class 2
  • Event Number
    Z-0948-2009
  • Event Initiated Date
    2008-12-29
  • Event Date Posted
    2009-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76977
  • 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
    Picture Archiving and Communications System - Product Code LLZ
  • Reason
    Product may display clinical reports with the study date and time in gmt format, which may not be obvious to the end user, who may expect to see the local time in the report.
  • Action
    Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.

Device

Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3
  • Model / Serial
    Versions 4.1.x up to and including 4.1.51.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
  • Product Description
    iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. || Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • Manufacturer Address
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA