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Merlin@Home Transmitter Software (2014-12-19)
- Starting date:
- December 19, 2014
- Posting date:
- January 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43367
Recalled Products
Merlin@Home Transmitter Software
Reason
St. Jude medical's post market surveillance system identified a low incidence of Merlin@Home Transmitters initiating a software reset backup operation in some implanted St. Jude medical devices with radio frequency (RF) capability. Potentially affected RF devices include all models of the St. Jude medical EllipseTM, Fortify AssuraTM, Implantable Cardioverter Defibrillators (ICD’s), Unify AssuraTM, Quadra AssuraTM, CRTD's and AssurityTM pacemakers including Assurity MRITM and AllureTM.
Affected products
Merlin@Home Transmitter Software
Lot or serial number
All lots.
Model or catalog number
Model EX1150, Version 7.0
Companies
- Manufacturer
-
St. Jude Medical,
Cardiac Rhythm Management Division,
15900 Valley View Court,
Sylmar
91342
California
UNITED STATES