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Medical Device

Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Recall date: 2026-07-22 · Source: FDA_DEVICE
Product
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason for recall
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).
Units affected
2 units
Description
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
View official recall notice →