The Recall Desk
ModerateFDA (Devices)·Z-2744-2026·Announced 2026-07-22

Photera 600 3-D phototherapy device UV sensor calibration error recall

Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.

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 a Class II recall with a calibration/measurement defect in a medical device. The source text does not report any illnesses, injuries, or hospitalizations. The hazard is a technical malfunction (incorrect gain setting) that affects device measurement accuracy rather than a direct safety failure, making it Moderate rather than High or above.

Plain-English summary

Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices used for treating dermatologic disorders. The devices are affected by a calibration error in which the UV sensor gain is being applied incorrectly at a level of approximately 4/5 instead of the correct setting of 7. This incorrect gain causes the device to report UV sensor counts at approximately 1000 instead of the correct level of approximately 5000, meaning the calibrated output is not calculating correctly.

The recalled devices were distributed nationwide. A total of 212 units with the affected serial numbers have been identified. Affected serial numbers are listed on the FDA website.

Patients and healthcare providers using affected devices should contact Daavlin Distributing Company for instructions on how to address the calibration error. The FDA classification for this recall is Class II.

The recalled product

Product
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Manufacturer
Daavlin Distributing Company
Category
Medical Device — Phototherapy / Dermatologic Device
Hazard
Affected units
212

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: 6-09278NB8CL
  • 6-09271NB8CL
  • 6-09055NB8CL
  • 6-09113NB8CL
  • 6-09204NB8CL
  • 6-09207NB8CL
  • 6-09116NB8CL
  • 6-09263NB8CL
  • 6-09272NB8CL
  • 6-09118NB8CL
  • 6-09275NB8CL
  • 6-09264NB8CL
  • 6-09060NB8CL
  • 6-09122NB8CL
  • 6-09216NB8CL
  • 6-09125NB8CL
  • 6-09353NB8CL
  • 6-09346NB8CL
  • 6-09128NB8CL
  • 6-09129NB8CL

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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