Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1600-2020 — 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 professionals to enabl

U.S. FDA — Device Enforcement · United States · 2020-02-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1600-2020
Date of alert: 2020-02-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Butterfly Network, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00866646000206

Reported risk: Distributed without an approved 510(k)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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