FDA DeviceClass IINotable
FDA Recall: Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
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).
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).
Remedy
26 units
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