Device product
Fisher Wallace Stimulator Models FW-100 and FW-200
Z-1600-2023
Product summary
- Event
- Event 91982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,489 total devices
- Official record key
device-enforcement:Z-1600-2023
Official wording
Reason: If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Code information: FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.