Device recall
Z-0094-2019: Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries…
FDA device recall · Class II · Widex A/S
Key facts
| Recall number (Z-number) | Z-0094-2019 |
|---|---|
| Recall event | 81085 |
| Product | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments. |
| Product code | ESD |
| Recalling firm | Widex A/S |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2018 |
| FEI number | 3003557127 |
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