Recall Z-1600-2023 ยท QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Fisher Wallace Laboratories Inc.
Fisher Wallace Stimulator Models FW-100 and FW-200
| Date | May 17, 2023 (initiated Apr 6, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 43,489 total devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B Medical Consultants Intl. , Ltd., Oct 4, 1990 |