Device product
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Z-1733-2026
Product summary
- Event
- Event 98513
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1733-2026
Official wording
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information: UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
Distribution pattern: US States: OH, PA, WA. China.
Derived failure modes
-
Unknown
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.