Reported Jul 19, 2023 · Ongoing
GE Healthcare Vivid S70N, ultrasound device
GE Vingmed Ultrasound As
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Vingmed Ultrasound As · Strandpromenaden 45 · Horten, N/A · N/A
Is this the product you have?
- GE Healthcare Vivid S70N, ultrasound device
- Lot codes and dates
- Software versions
v203v204v205v206
- Software versions
- Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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