Butterfly Network recalls iQ Ultrasound Auto Bladder Volume Tool with unapproved software versions 1.13.0-1.15.0 due to lack of 510(k) clearance. Affected healthcare professionals should check software version and contact for guidance.
Distributed without an approved 510(k)
Butterfly Network recalls the Auto Bladder Volume Tool for their iQ Ultrasound System that comes with unapproved software versions 1.13.0, 1.14.0, and 1.15.0. This means the tool may not meet safety standards for medical use, potentially causing harm if used incorrectly.
The tool was distributed without an approved 510(k) clearance, meaning it hasn't been tested or certified for safety and effectiveness by the FDA. This could lead to inaccurate measurements or other medical risks if used in patient care.
Healthcare professionals using Butterfly iQ Ultrasound System with the Auto Bladder Volume Tool and software versions 1.13.0, 1.14.0, or 1.15.0 are most at risk.
Check if your Butterfly iQ Ultrasound System has the Auto Bladder Volume Tool with software versions 1.13.0, 1.14.0, or 1.15.0. The UDI code (01)00866646000206 may help identify affected units.
Verify your device's software version is 1.13.0, 1.14.0, or 1.15.0 to determine if it's affected.
The recall states it was distributed without an approved 510(k), so it may not meet safety standards. The manufacturer recommends checking software versions and contacting them for guidance.
The recall does not specify a remedy, so contact Butterfly Network directly to get advice on next steps.
Check for software versions 1.13.0, 1.14.0, or 1.15.0 on the Butterfly iQ Ultrasound System. The UDI code (01)00866646000206 may help identify affected units.
We’ve drafted a message you can send Butterfly Network to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2020 — Butterfly Network Butterfly Network Hello, I own a Butterfly Network that is covered by recall Z-1600-2020 from Butterfly Network. 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.
