Recall
FDAHealthMarch 5, 2026

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

⚠️ 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).

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 5, 2026

US Nationwide distribution.

What's affected?

Product
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Lot code
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.

Additional details

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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 26 units.

View original FDA notice →

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