Home / Recalls / Daavlin Distributing Company / Z-1074-2022

Z-1074-2022 Class II Ongoing

Recalled by Daavlin Distributing Company — Bryan, OH

Recall Details

Product Type: Devices
Report Date: May 18, 2022
Initiation Date: April 26, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

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.

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.

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.

Code Information

UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020