FDAFDA · Food and drugs·Recall number Z-1561-2013
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.
Published June 26, 2013 · Recall initiated: March 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Linde Gas North America Llc
- Distributor
- Nationwide distribution.
- Lot
- Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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