Events

Recall of Device Recall Axis Gamma Camera

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
    45894
  • Event Risk Class
    Class 3
  • Event Number
    Z-1510-2008
  • Event Initiated Date
    2007-11-21
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66436
  • 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
    Scintillation (gamma) camera - Product Code KPS
  • Reason
    Resistor failure: the rotate motion shunt resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.
  • Action
    Consignees were sent an Urgent Field Safety Notice on 1/30/08. The letter instructs users who experience a failure to remove the system from service and contact the recalling firm for immediate correction. The recalling firm will schedule appointments with users to replace the affected part beginning in March 2008. For additional information, contact 1-800-722-9377.

Device

Device Recall Axis Gamma Camera
  • Model / Serial
    Model Numbers: 210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision 4535 671 67421, or N211282 Axis System 3/4 Precision (Note: Due to a part number scheme change at the firm, either number is representative of the identified system)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.
  • Product Description
    Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
  • 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