Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Reported: November 6, 2019 Initiated: October 3, 2019 #Z-0240-2020
Product Description
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Reason for Recall
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.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 6713 units
- Distribution
- Worldwide Distribution
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 6713 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0240-2020.
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