Device 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.
Z-1601-2020
Product summary
- Event
- Event 85178
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,183
- Official record key
device-enforcement:Z-1601-2020
Official wording
Reason: Distributed without an approved 510(k)
Code information: Software versions 1.10.0 through 1.15.0
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Distributed without an approved 510(k)