FDA-Device2019-11-06Class II
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
Sold states
Worldwide Distribution
Affected count
29544 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2020Don't want to check this manually?
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