Device Recall Phiips Medical Systems

  • Model / Serial
    Software versions: F.01.00 or F.01.01
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. || Used for the termination of ventricular tachycardia and ventricular fibrillation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
  • Source
    USFDA