Device recall
Z-1600-2020: Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume…
FDA device recall · Class II · Butterfly Network, Inc.
Key facts
| Recall number (Z-number) | Z-1600-2020 |
|---|---|
| Recall event | 85185 |
| Product | Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable… |
| 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