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Open, Classified

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

FDA Recall Z-2295-2026 · Posted 2026-06-02

Recalling FirmDaavlin Distributing Company
Recall StatusOpen, Classified
Product CodeFTC
Date Initiated2025-12-10
Product Quantity368 units

Reason for Recall

Some of the Calibration/Output Certificates had the outputs reversed.

Firm Action

An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers. Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed. Actions to be taken by the Customer/User: Talk to your physician regarding treatment plans with the new information listed below. If you have any questions or concerns, please do not hesitate to contact our office at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your cooperation.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K2208401 Series Phototherapy EquipmentDaavlin Distributing Co. · 2022-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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