FDA Device recall Z-1601-2020
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software version…
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software version… by Butterfly Network, citing distributed without an approved 510(k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1601-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-24 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Butterfly Network |
| Distribution | US |
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 anatomical structures.
Reason
Distributed without an approved 510(k)
Identifiers
| code_info | Software versions 1.10.0 through 1.15.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1601-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.