||June 20, 2013
||Terminated on February 03, 2015
|Recall Event ID
Regulator, pressure, gas cylinder -
||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.
||Model : Manufacturer's #M70500037
Cataogue Number: 109855
Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
|For Additional Information Contact
|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).
|Quantity in Commerce
||52,264 units (1106 units)
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.