Events

Recall of Device Recall iSite PACS with Advanced Visualization Tools (AVT)

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
    58044
  • Event Risk Class
    Class 2
  • Event Number
    Z-1881-2011
  • Event Initiated Date
    2011-02-23
  • Event Date Posted
    2011-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98095
  • 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 LLC
  • Reason
    A software anomaly that occurs when clinicians use volume vision to view images in 3d and uses the measurement tool to measure regions of interest. this could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.
  • Action
    Philips sent an Urgent Field Safety Notice letter dated February 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to assure that all colleagues were aware of the problem. When using the Volume Vision software, check the correctness of measurements (graphics and numerical values) prior to saving a captured image containing measurements. Save captured images containing measurements immediately after creating them and before altering the measurements in the original image view. For any subsequent measurements, create a new capture and save it immediately. For further information or support concerning this issues, customers should contact their local Philips representative at +1-877-328-2808.

Device

Device Recall iSite PACS with Advanced Visualization Tools (AVT)
  • Model / Serial
    All units of these iSite PACS.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; || Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system 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. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.
  • Manufacturer
    Philips Medical Systems

Manufacturer

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