The Recall Desk
ModerateFDA (Devices)·Z-2743-2026·Announced 2026-07-22

Photera 600 Phototherapy Device UV Sensor Calibration Error

Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a calibration/output measurement error. No illnesses or injuries are reported in the source text, and the hazard is a measurement inaccuracy rather than a structural or safety defect that directly causes harm. The error presents a potential for incorrect treatment dosing but falls short of the high-risk pathogen or allergen criteria that would warrant a higher score.

Plain-English summary

Daavlin Distributing Company is recalling the Photera 600, a phototherapy device used to treat dermatologic disorders. The recall affects 26 units with specific serial numbers distributed nationwide in the United States.

The device's UV sensor calibration is not calculating correctly. The gain setting applied to the sensor is incorrect, registering at approximately "4/5" instead of the proper setting of "7". This calibration error results in UV output counts of approximately 1000 instead of the correct level of approximately 5000, meaning the device may deliver inaccurate or incorrect ultraviolet light dosages during treatment.

Patients or healthcare facilities currently using affected units should contact Daavlin Distributing Company or consult their device documentation for instructions on how to proceed. The specific serial numbers affected are: 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, and 6-09042NB4CL.

The recalled product

Product
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Manufacturer
Daavlin Distributing Company
Category
Medical Device — Phototherapy / Dermatologic Device
Hazard
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Daavlin Distributing Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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