GE Vivid S70N Ultrasound Device Boot Failure Recall
GE Healthcare recalls certain Vivid S70N ultrasound devices that may not boot promptly, potentially delaying availability in time-critical emergencies.
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 medical device recall with no reported illnesses or injuries. The hazard is potential rather than realized—startup delays could impact emergency device availability—but the risk remains theoretical without documented harm.
Plain-English summary
GE Vingmed Ultrasound As is recalling certain Vivid S70N ultrasound systems due to a software-related startup defect. The affected devices operate software versions 203, 204, 205, or 206.
These ultrasound systems are distributed worldwide. Certain units may fail to boot up in a timely fashion. When this occurs, it delays the device's availability in time-critical emergency situations.
The startup defect was identified by the manufacturer. The recall is classified as FDA Class II, indicating a potential health hazard.
The recalled product
- Product
- GE Healthcare Vivid S70N, 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
Same manufacturer · GE Vingmed Ultrasound As
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