Photera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
Daavlin Distributing Company is recalling the Photera 400 phototherapy device because the UV sensor calibration is calculating incorrectly, resulting in lower output levels than intended.
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 error that affects device output but with no reported illnesses or injuries. The issue is a quantifiable technical defect in sensor gain calculation rather than a structural failure or contamination hazard.
Plain-English summary
Daavlin Distributing Company is recalling the Photera 400 phototherapy device (Serial Numbers 4-01440NB10CL and 4-01441NB10CL) distributed nationwide in the US due to a calibration error in the device's UV sensor gain setting.
The device's calibrated output was not calculating correctly because the UV sensor gain being applied was incorrect. The gain was set to approximately "4/5" instead of the correct value of "7," resulting in UV output counts of approximately 1000 instead of the intended 5000. This means the device may deliver lower ultraviolet output than intended for dermatologic treatment applications.
Patients and healthcare providers using this device should stop use and contact Daavlin Distributing Company for guidance on next steps. The manufacturer has been notified and can provide information regarding device replacement or corrective actions.
The recalled product
- Product
- Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Manufacturer
- Daavlin Distributing Company
- Affected units
- 2
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 (2)
- Serial Numbers: 4-01440NB10CL
- 2 4-01441NB10CL.
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.
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