Reported Apr 8, 2020 · Terminated
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI:…
Butterfly Network, Inc.
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: Butterfly Network, Inc. · 530 Old Whitfield St · Guilford, CT · 06437-3441
Is this the product you have?
- Butterfly iQ Ultrasound System containing the Auto
- EF(Ejection Fraction) Tool REF/Model850-20003
- UDI
(01)00866646000206 Software versions 1.10.01.11.01.12.01.13.01.13.01.14.01.15.0
- Product UsageIntended
- useDiagnostic ultrasound imaging and measurement of anatomical structures
- Lot codes and dates
- Software versions 1.10.0 through 1.15.0
- Amount recalled
- 11,183
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
- Nationwide
Why it was recalled
Distributed without an approved 510(k)
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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