Events

Recall of PINNACLE THERAPY PLANNING SYSTEM WITH IMRT AND IP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS MEDICAL SYSTEMS (CLEVELAND) 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
    71989
  • Event Risk Class
    II
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Software error.

Device

PINNACLE THERAPY PLANNING SYSTEM WITH IMRT AND IP
  • Model / Serial
    Model Catalog: (Lot serial: MODEL 9200-0579A); Model Catalog: (Lot serial: DEV LIC 30607)
  • Product Description
    PINNACLE THERAPY PLANNING SYSTEM
  • Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.

Manufacturer

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  • Manufacturer Address
    SAN JOSE
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC