Device recall
Z-2267-2015: OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For…
FDA device recall · Class II · Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Key facts
| Recall number (Z-number) | Z-2267-2015 |
|---|---|
| Recall event | 71583 |
| Product | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. |
| Product code | DQA |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2017 |
| 510(k) numbers | K123581 |
| FEI number | 2936999 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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