Device recall
Z-1437-2013: Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure)…
FDA device recall · Class II · Fisher & Paykel Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-1437-2013 |
|---|---|
| Recall event | 49033 |
| Product | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep… |
| Product code | BZD |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2013 |
| 510(k) numbers | K094040 |
| FEI number | 3002806988 |
At a glance
- 1–9 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