Device product
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
Z-1633-2023
Product summary
- Firm
- BearCare, Inc.
- Event
- Event 92275
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1818 units
- Official record key
device-enforcement:Z-1633-2023
Official wording
Reason: There have been reports of skin burns to children wearing the device.
Code information: Lot Number 20221115W002
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There have been reports of skin burns to children wearing the device.