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DAAVLIN

DAAVLIN DISTRIBUTING CO., THE · Model Phothera Pro HF · UDI-DI 00810182931005

FTC Prescription
1
510(k) clearances
120
Adverse events (1 deaths)
15
Recalls
26
Facilities

Description

PPHF UVA CL 10L

Recalls

DateFirmReason
2026-03-05Daavlin Distributing CompanyCalibrated 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).
2026-03-05Daavlin Distributing CompanyCalibrated 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).
2026-03-05Daavlin Distributing CompanyCalibrated 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).
2025-12-10Daavlin Distributing CompanySome of the Calibration/Output Certificates had the outputs reversed.
2022-04-26Daavlin Distributing CompanySoftware issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
2022-04-26Daavlin Distributing CompanySoftware issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
2017-01-27National Biological CorpThe wiring may allow the lamps to turn on with the key switch rather than the timer.
2013-04-09National Biological CorpThe incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
2013-04-08National Biological CorpThe incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
2008-02-19National Biological CorpSoftware allows operator to override "low line voltage" error warning and store light intensity value.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.