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.
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 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
- Affected units
- 14
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.
Part of a larger recall action
This product is one of 4 recalled by GE Vingmed Ultrasound As 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 4 products in this recall →Related recalls
Same manufacturer · GE Vingmed Ultrasound As
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