Device recall
Z-0300-2007: BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical…
FDA device recall · Class II · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-0300-2007 |
|---|---|
| Recall event | 36786 |
| Product | BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL… |
| Product code | DQA |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 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