Device recall
Z-1930-2013: TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1930-2013 |
|---|---|
| Recall event | 65843 |
| Product | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. |
| Product code | LPP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2014 |
| 510(k) numbers | K001866, K043003 |
| FEI number | 1523456 |
At a glance
- 1–9 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