Recall Z-1601-2020 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Butterfly Network, Inc.
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.
| Date | Mar 17, 2020 (initiated Feb 24, 2020) |
| Status | Terminated |
| Reason | Distributed without an approved 510(k) |
| Root cause | No Marketing Application |
| Action | Butterfly Network issued a correction notification via email on February 24, 2020 disabling the Auto EF Tool from affected devices operating software versions 1.10.0 through 1.15.0 for all affected US Butterfly iQ users and removed references of the Auto EF Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto EF Volume Tool until further notice. Questions related to this correction can be sent to Butterfly Network Customer Support via email at Support@butterflynetwork.com |
| Quantity | 11,183 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163510 | Poseidon Ultrasound System Butterfly Network, Inc., Sep 6, 2017 |