IQon Spectral CT Computed Tomography Xray system

  • Model / Serial
    860005, 860006, 860010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104. There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5. There were zero (0) Mexican accounts for this recall. The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    IQon Spectral CT Computed Tomography X-ray system, Model 728332
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA