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MERLIN@HOME TRANSMITTER SOFTWARE (2015-08-18)
- Starting date:
- August 18, 2015
- Posting date:
- October 5, 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-55220
Affected Products
MERLIN@HOME TRANSMITTER SOFTWARE
Reason
There is a second software anomaly in the Merlin™@home System that also has the potential to result in a reset into a back-up safety mode as a result of poor telemetry connection of the implanted devices.
Affected products
MERLIN@HOME TRANSMITTER SOFTWARE
Lot or serial number
Not applicable
Model or catalog number
AND PRIOR VERSIONS
VERSION 8.0,
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES