| 2026-03-02 |
Class II
|
Ongoing |
Z-1738-2026 |
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1737-2026 |
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1736-2026 |
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1735-2026 |
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1734-2026 |
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1733-2026 |
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1732-2026 |
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 |
— |
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 inc… |
| 2026-03-02 |
Class II
|
Ongoing |
Z-1731-2026 |
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 |
— |
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 inc… |
| 2025-05-01 |
Class II
|
Ongoing |
Z-1892-2025 |
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno… |
— |
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cov… |
| 2021-10-08 |
Class II
|
Terminated |
Z-0398-2022 |
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX |
— |
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| 2021-10-08 |
Class II
|
Terminated |
Z-0397-2022 |
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX |
— |
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| 2021-10-08 |
Class II
|
Terminated |
Z-0396-2022 |
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX |
— |
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| 2021-10-08 |
Class II
|
Terminated |
Z-0395-2022 |
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX |
— |
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |