System, Imaging, Pulsed Echo, Ultrasonic
FDA adverse event reports and recall history for system, imaging, pulsed echo, ultrasonic (product code IYO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,496
- Deaths
- 17
- Injuries
- 239
- Malfunctions
- 6,189
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2026-04-01Open, ClassifiedSoftware change control
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 incorrectly identified on the user interface.
- 2022-01-24Open, ClassifiedDevice Design
GE Vscan Extend, being sold as "Vscan Extend Console"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
- 2022-01-24Open, ClassifiedDevice Design
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
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