Device recall
Z-1619-2008: BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths…
FDA device recall · Class II · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-1619-2008 |
|---|---|
| Recall event | 47495 |
| Product | BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments. |
| Product code | DQA |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K020350 |
| FEI number | 2183502 |
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