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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85178

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 24, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Butterfly Network, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 anatomical structures.

Z-1601-2020
Recall number
Z-1601-2020
Initiated
February 24, 2020
Classification
Class II
Status
Terminated
Recalling firm
Butterfly Network, Inc.
Quantity
11,183

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Distributed without an approved 510(k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Distributed without an approved 510(k)

Code information

Software versions 1.10.0 through 1.15.0

Distribution pattern

US Nationwide distribution.