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
- Hazard
- calibration-error
- sensor-malfunction
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.
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