Official recall notice
FDA DeviceClass IINotable
FDA Recall: Innercool Coolblue Console, Model STx; Thermal regulating system.
- Recall date
- 2026-08-26
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Overheating of the 115V CPU board may cause the device to shut down.
Product description
Overheating of the 115V CPU board may cause the device to shut down.
Affected products
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277