Device Recall MEDICYCLE Lite Portable Oxygen System

  • Modèle / numéro de série
    Model : Manufacturer's #M70500037 Cataogue Number: 109855   Lot numbers:  25/07 48/06 20/03
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Linde Gas North America Llc, 575 Mountain Ave, Attn Import Compliance Manager, New Providence NJ 07974
  • Société-mère du fabricant (2017)
  • Source
    USFDA