Device recall
Z-1561-2013: MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery…
FDA device recall · Class II · Linde Gas North America Llc
Key facts
| Recall number (Z-number) | Z-1561-2013 |
|---|---|
| Recall event | 64856 |
| 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… |
| Product code | CAN |
| Recalling firm | Linde Gas North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2015 |
| FEI number | 3007529772 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database