Device recall
Z-2777-2026: Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow…
FDA device recall · Class II · Emano Metrics, Inc.
Key facts
| Recall number (Z-number) | Z-2777-2026 |
|---|---|
| Recall event | 99241 |
| Product | Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed digitally via mobile… |
| Product code | EXY |
| Recalling firm | Emano Metrics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3021350028 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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