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U.S. Department of Health and Human Services

Class 2 Device Recall Fisher Wallace Stimulator

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 Class 2 Device Recall Fisher Wallace Stimulatorsee related information
Date Initiated by FirmApril 06, 2023
Date PostedMay 17, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1600-2023
Recall Event ID 91982
510(K)NumberK903654 
Product Classification Cranial electrotherapy stimulator to treat insomnia and/or anxiety - Product Code QJQ
ProductFisher Wallace Stimulator Models FW-100 and FW-200
Code Information FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
FEI Number 3006258094
Recalling Firm/
Manufacturer		 Fisher Wallace Laboratories Inc.
630 Flushing Ave Ste 104
Brooklyn NY 11206-5775
For Additional Information ContactDiana Aghabekian
800-692-4380
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE CORRECTION dated 4/6/23 was sent to customers. Short term actions to be taken by the User: 1. Always ensure the batteries are inserted correctly into the device (see above diagram). 2. Do not leave batteries in the device when the device is not in use (e.g. in between a morning and evening treatment). 3. Do not fall asleep while using the device because corrective actions cannot be taken when the user is asleep. 4. If the device exhibits excess heat, burning smell, or odor, turn off the device, and discontinue use. Contact Fisher Wallace Laboratories immediately. The long term corrective action by the company is still being determined. We request your action by replying to this email to confirm that you understand the information in this medical device correction and the subsequent actions needed to be taken. Fisher Wallace apologizes for any inconvenience this may cause. If you have any questions about what to do with your product, please contact Fisher Wallace by telephone Monday - Friday, 10:00 AM to 6:00 PM, Eastern Time at (800) 692-4380 or by email at postmarketsurveillance@fisherwallace.com.
Quantity in Commerce43,489 total devices
DistributionUS Nationwide. Global Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QJQ
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