Device recall
Z-0176-06: Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or…
FDA device recall · Class III · Datascope Corp
Key facts
| Recall number (Z-number) | Z-0176-06 |
|---|---|
| Recall event | 33724 |
| Product | Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive… |
| Product code | DRT |
| Recalling firm | Datascope Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 6, 2007 |
| 510(k) numbers | K031849 |
| FEI number | 2221819 |
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