Device recall
Z-1557-2026: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1557-2026 |
|---|---|
| Recall event | 98407 |
| Product | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product… |
| Product code | MWI |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160718 |
| FEI number | 2936999 |
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