Fisher Wallace Stimulator Models FW-100 and FW-200

FDA device recall Z-1600-2023 · posted 2023-05-17 · Open, Classified

Recall details

Recalling firm

Fisher Wallace Laboratories Inc.

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.

Action taken

An 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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

QJQ

Quantity affected

43,489 total devices

Distribution

US Nationwide. Global Distribution.

Date initiated

2023-04-06

Date posted

2023-05-17

Location

NY

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