Recall Z-1561-2013— Linde Gas North America Llc
Class II · Terminated
Class II FDA medical device recall by Linde Gas North America Llc, initiated 2013-03-08, terminated 2015-02-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs..
- Recalling firm
- Linde Gas North America Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-08
- Terminated
- 2015-02-03
- Firm location
- New Providence, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.