Events

Recall of View Forum 2003 software, SW 3.4L1

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
    31997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-05
  • Event Initiated Date
    2005-04-29
  • Event Date Posted
    2005-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38888
  • 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
    Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the philips allura fd10.
  • Action
    On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.

Device

View Forum 2003 software, SW 3.4L1
  • Model / Serial
    The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were distributed to 18 medical centers thorughout the US.
  • Product Description
    View Forum 2003 software, SW 3.4L1
  • 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