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Recall Observatory FDA recall evidence

Device product

Fisher Wallace Stimulator Models FW-100 and FW-200

Z-1600-2023

April 06, 2023

Class II

Product summary

Firm
Fisher Wallace Laboratories Inc.
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

    reason.no_named_rule · v1.0.0

    If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.