Events

Recall of Device Recall Gamma Camera System, Tomography, Computed, Emission

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems 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
    25518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0563-03
  • Event Initiated Date
    2003-01-23
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25965
  • 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, Tomography, Computed, Emission - Product Code KPS
  • Reason
    The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
  • Action
    The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.

Device

Device Recall Gamma Camera System, Tomography, Computed, Emission
  • Model / Serial
    All serial numbers of Models N210060 and N210335.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The sytems were shipped to end-users located nationwide and worldwide.
  • Product Description
    Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
  • Manufacturer
    Philips Medical Systems Inc

Manufacturer

Philips Medical Systems Inc
  • Manufacturer Address
    Philips Medical Systems Inc, 595 Miner Rd, Cleveland OH 44143
  • Source
    USFDA