Events

Recall of SKYLight Gamma Camera System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    60021
  • Event Risk Class
    Class 2
  • Event Number
    Z-0249-2012
  • Event Date Posted
    2011-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104251
  • 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
    A mechanical malfunction of the button on the hand controller on the philips precedence and skylight spect systems may get stuck and cause unintended motion of a detector.
  • Action
    Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.

Device

SKYLight Gamma Camera System
  • Model / Serial
    Model numbers: 2160-3000A 4535-600-66661
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico.
  • Product Description
    SKYLight Gamma Camera System; || SKYLIGHT, 3/8",SPECT; || Manufactured by Philips Medical Systems (Cleveland), Inc. || 595 Miner Road, Cleveland, OH 44143. || The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA