GE Healthcare Vivid S70 ultrasound systems fail to boot timely
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
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 a risk-of-harm product (medical device) with no reported illnesses or injuries. The hazard is operational and theoretical, fitting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE Healthcare Vivid S70 ultrasound systems are affected by a startup delay issue. Certain units cannot boot up in a timely fashion, which can reduce equipment availability during time-critical emergency situations.
The recall affects 14 units worldwide. The devices affected run software versions V203 or V204. This is classified as a Class II medical device recall.
The recalled product
- Product
- GE Healthcare Vivid S70, ultrasound device
- Manufacturer
- GE Vingmed Ultrasound As
- Hazard
- boot-failure
- emergency-delay
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 (2)
- Software versions: V203
- v204
Distribution
Distribution scope not specified by the agency.
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