Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)008666460002
FDA device recall Z-1601-2020 · posted 2020-03-17 · Terminated
Recall details
- Recalling firm
- Butterfly Network, Inc.
- Reason for recall
- Distributed without an approved 510(k)
- Action taken
- 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
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 11,183
- Distribution
- US Nationwide distribution.
- Date initiated
- 2020-02-24
- Date posted
- 2020-03-17
- Date terminated
- 2020-06-12
- Location
- Guilford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Poseidon Ultrasound System (K163510) | Butterfly Network, Inc. | 2017-09-06 |