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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:167425

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 recall number

Z-0094-2019

Evidence summary

Product code
ESD
Recall status
Terminated
Event initiated
August 31, 2018
Root cause
Employee error
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0094-2019

Field note

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