Reported Jul 17, 2024 · Ongoing

GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

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 Vivid Ultrasound products
  • Model Numbers
    • a) Vivid E90
    • H45581LB
    • b) Vivid E95
    • H45581DA
Lot codes and dates
  • a) H45581LB, UDI/DU *
  • Serial Numbers
    • AU01170
    • AU01180
    • AU50159
    • b) H45581D
    • UDI/DI *
  • Serial numbers
    • AU01095
    • AU50476
    • AU50252
    • AU01002
Amount recalled
7 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.