FDA-Device2019-02-13Class II
MEDTRONIC CARELINK 2090 programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
Sold states
US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
Affected count
33007 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
MEDTRONIC CARELINK 2090 programmer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2019Don't want to check this manually?
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