Device recall
Z-1812-2020: H12+ and patient cable for the H12+ Holter Recorders with the following device…
FDA device recall · Class II · WELCH ALLYN, INC/MORTARA
Key facts
| Recall number (Z-number) | Z-1812-2020 |
|---|---|
| Recall event | 85297 |
| Product | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide… |
| Product code | DPS |
| Recalling firm | WELCH ALLYN, INC/MORTARA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2026 |
| 510(k) numbers | K050896 |
| 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