Z-1561-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2013
- Initiation Date
- March 8, 2013
- Termination Date
- February 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,264 units (1106 units)
Product Description
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.
Reason for Recall
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Distribution Pattern
Nationwide distribution.
Code Information
Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03