Events

Recall of Philips Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    49520
  • Event Risk Class
    Class 2
  • Event Number
    Z-0132-2009
  • Event Initiated Date
    2008-09-22
  • Event Date Posted
    2008-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73718
  • 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
    pulmonary toolkit - Product Code KPS
  • Reason
    Images not correlated: a leak between the tube interface and the outlet tube of the transducer may result in a failure to produce respiratory correlated images.
  • Action
    On 9/8/2008 Philips Medical Systems sent recall notification letters to their customers requesting they inventory their stock. They sent instructions to verify that the product is working properly. They are also sending Field Service Engineers to each customer to conduct field test.

Device

Philips Medical
  • Model / Serial
    All units of Model numbers 455011203131 and 455011203191.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic, Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea, Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa, Saudi Arabia, Spain, Switzerland, Sweden, and Thailand.
  • Product Description
    Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA