Events

Recall of Device Recall BrightView Gamma Camera Radius Drive

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Phillips Nuclear Medicine.

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
    52704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1892-2009
  • Event Initiated Date
    2009-07-02
  • Event Date Posted
    2009-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83681
  • 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
    Emission computed tomography system - Product Code KPS
  • Reason
    Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.
  • Action
    Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.

Device

Device Recall BrightView Gamma Camera Radius Drive
  • Model / Serial
    All units: 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 || Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Phillips Nuclear Medicine

Manufacturer

Phillips Nuclear Medicine
  • Manufacturer Address
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA