FDA-Device2013-06-26Class II
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.
Linde Gas North America Llc
Hazard
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Sold states
Nationwide distribution.
Affected count
52,264 units (1106 units)
Manufactured in
575 Mountain Ave, Attn Import Compliance Manager, New Providence, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2013Don't want to check this manually?
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