Device recall
Z-1326-2009: Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog…
FDA device recall · Class II · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-1326-2009 |
|---|---|
| Recall event | 50740 |
| Product | Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU… |
| Product code | CCK |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K010770, K011177 |
| FEI number | 2183502 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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