Device recall
Z-1695-2025: Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological…
FDA device recall · Class II · Spectrum Medical Ltd.
Key facts
| Recall number (Z-number) | Z-1695-2025 |
|---|---|
| Recall event | 96616 |
| Product | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk… |
| Product code | MWI |
| Recalling firm | Spectrum Medical Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3006073153 |
At a glance
- None 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