Daavlin Distributing Company: Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

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).

Details from the source

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). Distribution: US Nationwide distribution. Quantity: 26 units Lot/code info: Serial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.