Devices

Device Recall HeartStart MRx Monitor/Defibrillator

  • Modèle / numéro de série
    US00588464, US00588657, US00589878, US00591080, US00593861
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
  • Description du dispositif
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) || Product Automated external defibrillators (non-wearable) || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Electronics North America Corporation
  • 1 Event

Fabricant

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA

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Device Recall HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Serial Numbers:  US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
  • Description du dispositif
    MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
    Philips Electronics North America Corporation