High FDA (Devices)·Z-0524-2022·Announced 2022-02-02

GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical ultrasound device, which is a risk-of-harm product used in healthcare settings. No injuries or adverse events have been reported, but device failure could potentially delay or prevent diagnostic care.

Plain-English summary

GE Healthcare, LLC is recalling the Vscan Extend Sector Wi-Fi, a portable ultrasound system.

The company identified that the Vscan Extend device will not power on when the battery becomes depleted. This can occur when the device is not turned off before the battery is removed, or when the device is connected to a computer without access to AC power.

Approximately 44 units of this model have been distributed domestically across the United States and internationally to over 80 countries including Canada, the United Kingdom, Germany, France, India, China, Japan, and Australia.

Healthcare facilities and users are encouraged to contact GE Healthcare for additional information regarding this recall.

The recalled product

Product: GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Diagnostic Ultrasound
Hazard: power-failure
battery-depletion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Information reads "Serial Number (UDI
Model Number)". VH200223DX (01008406821216511120100821VH200223DX
H41212ZD)
VH150287BJ (01008406821216511118010021VH150287BJ
H41212RS)
VH200066HU (01008406821216511119120021VH200066HU
VH200162ER (01008406821216511120071621VH200162ER
H41212ZC)
VH20016794 (01008406821216511120071521VH20016794
VH150601D6 (01008406821216511119011821VH150601D6
VH200230XX (01008406821216511120071621VH200230XX
VH200169VK (01008406821216511120071521VH200169VK
VH200237TC (01008406821216511120071621VH200237TC
VH200132U6 (01008406821216511120010021VH200132U6
VH150275W5 (01008406821216511117090021VH150275W5
VH1504669B (01008406821216511118110021VH1504669B
VH1508481L (01008406821216511119090021VH1508481L
VH150284N3 (01008406821216511117100021VH150284N3
VH150265SH (01008406821216511117070021VH150265SH
VH1502694X (01008406821216511117070021VH1502694X

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · GE Healthcare, LLC

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Same hazard · power failure