Device product
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Z-1522-2021
Product summary
- Event
- Event 87654
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,311 devices
- Official record key
device-enforcement:Z-1522-2021
Official wording
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Code information: All serial numbers
Distribution pattern: Worldwide
Derived failure modes
-
Device software or design
software issue