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.
- Company
- Daavlin Distributing Company
- Recall Initiated
- April 26, 2022
- Recall Number
- Z-1074-2022
- Quantity
- 1
- Firm Location
- Bryan, OH
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
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.
Lot / Code Info
UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
Root Cause
Software Design Change
Action Taken
Beginning April 26, 2022 Daavlin Distributing Co. is sent a recall notification letter via certified mail to customers. Customers are to acknowledge receipt of the notification and a company representative will call customers to arrange for return of the devices to update software. If you have any questions or concerns, contact the company at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, EST.