FDA-Device2018-10-17Class II
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.
Widex A/S
Hazard
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
Sold states
US Distribution to states of: GA and NY.
Affected count
2
Manufactured in
Nymollevej 6, Lynge, Denmark
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2019Don't want to check this manually?
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