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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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.
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