Butterfly Network recalls iQ Ultrasound System with Auto EF Tool (model 850-20003) due to unapproved software versions. Affected units may not be safe for medical use.
Distributed without an approved 510(k)
Butterfly Network is recalling ultrasound systems with the Auto EF Tool that have specific software versions. This recall is because the software was distributed without proper regulatory approval, which could affect medical safety.
The software versions were distributed without approval from the FDA, meaning they might not meet safety and effectiveness standards. This could lead to incorrect medical measurements or device malfunctions during use.
Medical professionals using the Butterfly iQ Ultrasound System with the Auto EF Tool and specific software versions are likely affected. Patients using these devices may also be at risk if the device is not properly regulated.
Check for the model number 850-20003 on the device. The software versions 1.10.0 through 1.15.0 are affected. The device may have a unique identifier (UDI) starting with (01)00866646000206.
Look for the model number 850-20003 on the device.
Check if the software version is between 1.10.0 and 1.15.0.
The software versions were distributed without FDA approval, which could affect medical safety.
The recall record does not specify a remedy, so contact Butterfly Network directly for guidance.
The recall indicates potential safety issues due to unapproved software, but the exact risk is not detailed in the record.
We’ve drafted a message you can send Butterfly to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2020 — Butterfly Butterfly Hello, I own a Butterfly that is covered by recall Z-1601-2020 from Butterfly. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
