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Recall Observatory FDA recall evidence

Device 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.

Z-1074-2022

April 26, 2022

Class II

Product summary

Firm
Daavlin Distributing Company
Event
Event 89990
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1074-2022

Official wording

Reason: 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.

Code information: UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue