Device recall
Z-1853-2021: v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model…
FDA device recall · Class II · Abbott Laboratories Inc. (St Jude Medical)
Key facts
| Recall number (Z-number) | Z-1853-2021 |
|---|---|
| Recall event | 87904 |
| Product | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP… |
| Product code | DQK |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2024 |
| 510(k) numbers | K210392 |
| FEI number | 1000139754 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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