GE Healthcare Vivid S60N ultrasound devices experience boot-up delays
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device 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 (emergency ultrasound device) where injury has not been reported. While classified as FDA Class II, no hospitalization or injury reports accompany it, placing it at High per the rubric's criteria for risk-of-harm products without reported harm.
Plain-English summary
GE Healthcare has identified an issue with certain Vivid S60N ultrasound systems manufactured by GE Vingmed Ultrasound As. The affected systems cannot boot up in a timely fashion, which can delay device availability during time-critical emergency situations.
The recall involves software versions v203, v204, v205, and v206 of the Vivid S60N. These devices have been distributed worldwide. The delayed boot time prevents the device from being ready for immediate use in emergency settings.
Healthcare facilities using affected systems should contact GE Healthcare or consult the FDA recall notice (Z-2126-2023) for guidance on corrective actions.
The recalled product
- Product
- GE Healthcare Vivid S60N, ultrasound device
- Manufacturer
- GE Vingmed Ultrasound As
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 (4)
- Software versions: v203
- v204
- v205
- v206
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
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