Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0949-2015 — Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

U.S. FDA — Device Enforcement · United States · 2014-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0949-2015
Date of alert
2014-12-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
St Jude Medical Cardiac Rhythm Management Division
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
25117181
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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