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
  • 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
  • 1 Event

Manufacturer

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