FDAHealthMarch 5, 2026
Daavlin Distributing Company — Photera 400, 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 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Lot code
- Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.
Additional details
Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.
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