Drug recall
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF…
FDA recall event 70066 · Class II · St Jude Medical Cardiac Rhythm Management Division
Key facts
| Event ID | 70066 |
|---|---|
| Recall numbers | Z-0949-2015 |
| Recalling firm | St Jude Medical Cardiac Rhythm Management Division |
| Product type | Devices |
| Products | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura… |
| Initiation date | Dec 18, 2014 |
| Report date | Jan 21, 2015 |
| Termination date | Mar 30, 2016 |
| City | Sylmar |
| State | CA |
| Country | United States |
| FEI number | 2017865 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: