Reported Jan 21, 2015 · Terminated
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote…
St Jude Medical Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
Merlin@home RF Remote Monitoring TransmitterModel EX1150with software versions 6.1M or 7.0
- UsageRF Remote Transmitter
- Lot codes and dates
- Serial No.
3,259 of 3,259 codes
251171812510295725087732250894151242546325095596251846821248583925102906251541032510891825025302123814432503845525092708122211702511213625169594251372282509361525141686251174582511160425093649251325462510393925138550251415402509569825083041122042741229600725162338250720032509682725136903250916782515916425111804251694422506992112376794250742372508387625136384250646171229759925091439250680342517214625074154250741902507785225064811123515132507480125083477122999372514771625078787
- Serial No.
- Amount recalled
- 257,456 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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