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 corpus and the live FDA recall database.
- Total reports
- 6,627
- Deaths
- 17
- Injuries
- 241
- Malfunctions
- 6,318
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-25Open, ClassifiedSoftware Design Change
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- 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.
- 2022-01-24TerminatedDevice 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.
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