Official recall notice
FDA DeviceClass IINotable
FDA Recall: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Recall date
- 2026-07-22
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Product description
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Affected products
Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.