Device recall
Z-0234-06: Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with…
FDA device recall · Class III · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-0234-06 |
|---|---|
| Recall event | 33375 |
| Product | Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO3 option, Invasive Pressure/Temperature and battery. |
| Product code | DPS |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 27, 2007 |
| 510(k) numbers | K010770, K011177 |
| FEI number | 2183502 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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