Device product

eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

Z-1737-2026

March 02, 2026

Class II

Product summary

Firm: Civco Medical Instruments Co. Inc.
Event: Event 98513
Status: Ongoing
Classification: Class II
Quantity: 10 units
Official record key: device-enforcement:Z-1737-2026

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: 00841436111096; Lot Number: A276636, A282454

Distribution pattern: US States: OH, PA, WA. China.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.