medical Class II Updated 2022-05-18

Daavlin Distributing Company recalls 4 Series CX phototherapy units equipped with Daavlin's Clear

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
View official government recall

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