Phothera 200 phototherapy calibration certificates had outputs reversed
Phothera 200 phototherapy devices are being recalled because some Calibration and Output Certificates had the outputs reversed. 368 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where reversed calibration outputs could lead to an incorrect treatment dose being set, a risk of harm with no injuries reported.
Plain-English summary
Phothera 200 phototherapy devices, model numbers 210NDT4 and 210NC, indicated for treating diagnosed skin disorders including psoriasis, vitiligo and atopic dermatitis under the direction of a physician, are being recalled. The action covers 368 units, identified by the serial numbers in the recall notice.
The stated reason is that some of the Calibration/Output Certificates had the outputs reversed. The certificates document the device's measured light output, which clinicians use when setting treatment doses. The FDA classified the action as Class II.
Distribution was nationwide in the United States. The devices are supplied for use under physician direction.
Facilities and prescribers should identify affected units using the model and serial numbers in the recall notice and follow the instructions issued by the manufacturer, including any guidance on re-checking treatment settings.
The recalled product
- Product
- Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
- Manufacturer
- Daavlin Distributing Company
- Hazard
- calibration-error
- reversed-outputs
- dosing-error
- class-ii
- phototherapy
Distribution
Distributed nationwide across the United States.
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