Daavlin Distributing Company: Medical Device Recall in 2022 - (Recall #: Z-1074-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 26, 2022

Date Posted: May 18, 2022

Recall Number: Z-1074-2022

Event ID: 89990

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1

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.

Voluntary or Mandated:

Voluntary: Firm initiated