Butterfly iQ Ultrasound System Auto Bladder Volume Tool Recalled for Regulatory Violation
Butterfly Network, Inc. is recalling the Butterfly iQ Ultrasound System Auto Bladder Volume Tool because it was distributed without an approved 510(k).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites a regulatory violation (distribution without an approved 510(k)) rather than a specific physical hazard or reported injury, aligning with the criteria for moderate severity.
Plain-English summary
Butterfly Network, Inc. is recalling the Butterfly iQ Ultrasound System Auto Bladder Volume Tool, a segmentation measurement tool. The recall involves software versions 1.13.0, 1.14.0, and 1.15.0, identified by REF/Model 850-20003 and UDI (01)00866646000206.
The recall was initiated because the product was distributed without an approved 510(k). The Butterfly 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.
The recall affects 15,121 host devices distributed nationwide in the United States. Healthcare professionals should contact Butterfly Network, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare pr
- Manufacturer
- Butterfly Network, Inc.
- Hazard
- Affected units
- 15,121
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 (3)
- Software versions 1.13.0
- 1.14.0
- and 1.15.0 UDI: (01)00866646000206
Distribution
Distributed nationwide across the United States.
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