Butterfly iQ Ultrasound System Recalled for Lack of FDA Approval
Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Butterfly Network, Inc. is recalling 11,183 units of the Butterfly iQ Ultrasound System containing the Auto EF (Ejection Fraction) Tool. The affected software versions are 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.14.0, and 1.15.0. The product is identified by REF/Model 850-20003 and UDI (01)00866646000206.
The recall was initiated because the devices were distributed without an approved 510(k). The intended use of the system is diagnostic ultrasound imaging and measurement of anatomical structures.
The affected units were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected software versions and contact Butterfly Network, Inc. for further instructions.
The recalled product
- Product
- Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of…
- Manufacturer
- Butterfly Network, Inc.
- Affected units
- 11,183
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 (1)
- Software versions 1.10.0 through 1.15.0
Distribution
Distributed nationwide across the United States.
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