Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1561-2013 — 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

U.S. FDA — Device Enforcement · United States · 2013-03-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1561-2013
Date of alert: 2013-03-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Linde Gas North America Llc
Product category: device
Product type: Devices

Reported risk: A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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