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Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLin
Recalled May 11, 2016 · FDA recall Z-1605-2016 · Medtronic Inc., Cardiac Rhythm and Heart Failure
Hazard
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 cou · FDA Class II
Units
5038
Sold at
AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
Description
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 cou
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.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →