Ultrasound Device Boot Failure May Delay Emergency Availability
Certain GE HealthCare Vivid S60 ultrasound systems may not boot up in a timely fashion, potentially delaying device availability in 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 Class II FDA medical device recall with no reported illnesses or injuries. The hazard is theoretical—potential delay in device availability in time-critical situations—without actual harm documented. Per the rubric, risk-of-harm products without reported injury are scored at 3.
Plain-English summary
GE HealthCare has identified that certain Vivid S60 ultrasound systems may not boot up in a timely fashion. The affected systems run software versions v203 or v204 and have been distributed worldwide, with 2 units identified as affected.
When boot-up failures occur, they can delay the availability of the device in time-critical emergency situations. Users with a Vivid S60 system should verify which software version their system is running and contact GE Vingmed Ultrasound As if they have the affected software versions v203 or v204.
The recalled product
- Product
- GE Healthcare Vivid S60, ultrasound device
- Manufacturer
- GE Vingmed Ultrasound As
- Affected units
- 2
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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