Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .
Date of Enforcement Report 5/11/2016
Class lI:
PRODUCT
Medtronic CareLink” Monitor (2490C) and Medtronic CareLink Express” Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.
Recall Number Z-1605-2016
REASON
A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select countries.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN on 3/31/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5038
DISTRIBUTION
Internationally
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