Reported Apr 8, 2020 · Terminated
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool…
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 Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a
- segmentation measurement tool REF/Model
850-20003 Software versions 1.13.01.14.0and 1.15.0 -
- Product UsageButterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients
- Lot codes and dates
Software versions 1.13.01.14.0and 1.15.0
- UDI(01)00866646000206
- Amount recalled
- 15,121 host devices
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.
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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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