Daavlin Distributing Company: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
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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 400, 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: 4-01440NB10CL, 2 4-01441NB10CL.
- Product quantity
- 2 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bryan
- State
- OH
- Country
- United States
- Event id
- 99331
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