Device recall
Z-2032-2023: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor…
FDA device recall · Class I · GE Healthcare Finland Oy
Key facts
| Recall number (Z-number) | Z-2032-2023 |
|---|---|
| Recall event | 92455 |
| Product | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) |
| Product code | DPZ |
| Recalling firm | GE Healthcare Finland Oy |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K040831 |
| FEI number | 3002806783 |
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