Z-1600-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,489 total devices
Product Description
Fisher Wallace Stimulator Models FW-100 and FW-200
Reason for Recall
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T