Device recall
Z-1453-06: TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash…
FDA device recall · Class III · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1453-06 |
|---|---|
| Recall event | 35696 |
| Product | TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component) |
| Product code | KLK |
| Recalling firm | Radiometer America Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| FEI number | 1523456 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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