Recall Z-0094-2019— Widex A/S
Class II · Terminated
Class II FDA medical device recall by Widex A/S, initiated 2018-08-31, terminated 2018-12-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Widex A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-31
- Terminated
- 2018-12-21
- Firm location
- Lynge, Denmark
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.