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

Medical DevicesSource: FDA (device) · Date: 2026-07-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Daavlin Distributing Company
Product
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason / 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).
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-03-05
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.
Product quantity
26 units
Voluntary mandated
Voluntary: Firm initiated
City
Bryan
State
OH
Country
United States
Event id
99331
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