Device recall
Z-0177-06: Passport 2 with View 12 ECG Analysis Module. It is a transportable…
FDA device recall · Class III · Datascope Corp
Key facts
| Recall number (Z-number) | Z-0177-06 |
|---|---|
| Recall event | 33724 |
| Product | Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood… |
| Product code | DRT |
| Recalling firm | Datascope Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 6, 2007 |
| 510(k) numbers | K020550 |
| 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