Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .
Date of Enforcement Report 7/13/2016
Class lI:
PRODUCT
Medtronic, MyCareLink” Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Recall Number Z-2125-2016
REASON
ARecently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink” Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN on 5/26/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
262
DISTRIBUTION
Internationally
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