Daavlin Distributing Company

3 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices

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

Class I - Dangerous

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

Dec 10, 2025 Other Medical Devices Nationwide View Details →

1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

Class I - Dangerous

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Apr 26, 2022 Other Medical Devices Nationwide View Details →

4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

Class I - Dangerous

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Apr 26, 2022 Other Medical Devices Nationwide View Details →