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.
Recall
- Recall Number
- Z-1561-2013
- Event Number
- 64856
- Firm
- Linde Gas North America Llc 575 Mountain Ave Attn Import Compliance Manager New Providence NJ 07974
- FEI Number
- 3007529772
- Product Code
- CAN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 8, 2013
- Posted
- June 20, 2013
- Terminated
- February 3, 2015
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.
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance. If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action. Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427).
Nationwide distribution.
52,264 units (1106 units)