FDA Device recall Z-0949-2015
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter by St Jude Medical Cardiac Rhythm Management Division, citing transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-18 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason
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 ICDs and Assurity and Allure Pacemakers.
Identifiers
| code_info | Serial No. 25117181 25102957 25087732 25089415 12425463 25095596 25184682 12485839 25102906 25154103 2510891…Serial No. 25117181 25102957 25087732 25089415 12425463 25095596 25184682 12485839 25102906 25154103 25108918 25025302 12381443 25038455 25092708 12221170 25112136 25169594 25137228 25093615 25141686 25117458 25111604 25093649 25132546 25103939 25138550 25141540 25095698 25083041 12204274 12296007 25162338 25072003 25096827 25136903 25091678 25159164 25111804 25169442 25069921 12376794 25074237 25083876 25136384 25064617 12297599 25091439 25068034 25172146 25074154 25074190 25077852 25064811 12351513 25074801 25083477 12299937 25147716 25078787 25111411 12333835 25157659 25120763 25072304 25083123 25115365 25065318 12243413 25046069 12241670 12345709 12430239 25151639 25013443 25194240 12440854 12490301 12365721 12307572 25151201 25073392 25137086 25075167 12212657 25023097 12201701 12436413 25090438 25162500 25084216 25074239 25122865 25064060 25078847 25081883 25158300 25156425 25108020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2015%22
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