Device recall
Z-0033-2018: Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models…
FDA device recall · Class II · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-0033-2018 |
|---|---|
| Recall event | 78093 |
| Product | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable… |
| Product code | OSR |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2020 |
| PMA numbers | P910023, P910023S386 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 10–99 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