Recall Z-0094-2019 ยท ESD Hearing Aid, Air-Conduction, Prescription
Widex A/S
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.
| Date | Aug 31, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | The firm, Widex, sent an "Urgent Medical Device Correction Letter" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: a) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted. b) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted. If you have any questions, contact D |
| Quantity | 2 |
| Distribution | US Distribution to states of: GA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.