Device recall
Z-1815-2020: S4 and patient cable for the S4 Wireless Telemeter with the following device…
FDA device recall · Class II · WELCH ALLYN, INC/MORTARA
Key facts
| Recall number (Z-number) | Z-1815-2020 |
|---|---|
| Recall event | 85297 |
| Product | S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire… |
| Product code | DPS |
| Recalling firm | WELCH ALLYN, INC/MORTARA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2026 |
| 510(k) numbers | K160685 |
| FEI number | 2183461 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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