Device recall
Z-1601-2020: Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool…
FDA device recall · Class II · Butterfly Network, Inc.
Key facts
| Recall number (Z-number) | Z-1601-2020 |
|---|---|
| Recall event | 85178 |
| 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. |
| Product code | IYN |
| Recalling firm | Butterfly Network, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2020 |
| 510(k) numbers | K163510 |
| FEI number | 3010102386 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database