Device product
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Z-1734-2026
Product summary
- Event
- Event 98513
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1734-2026
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: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840
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.