Device recall
Z-1240-2007: BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers…
FDA device recall · Class III · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-1240-2007 |
|---|---|
| Recall event | 38472 |
| Product | BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc |
| Product code | DQA |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 31, 2008 |
| 510(k) numbers | K981939 |
| 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