Device Recall MEDICYCLE Lite Portable Oxygen System

  • Modelo / Serial
    Model : Manufacturer's #M70500037 Cataogue Number: 109855   Lot numbers:  25/07 48/06 20/03
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    MEDICYCL-E- Lite Portable Oxygen System || An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Linde Gas North America Llc, 575 Mountain Ave, Attn Import Compliance Manager, New Providence NJ 07974
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA