FDA (Devices) recall action 89102
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.
GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer without AC power.
GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.
GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting without AC power.
GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when the device is not turned off before battery removal or is connected to a computer without AC power.
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.