Device product
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.
Z-1561-2013
Product summary
- Event
- Event 64856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52,264 units (1106 units)
- Official record key
device-enforcement:Z-1561-2013
Official wording
Reason: A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Code information: Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.