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.
FDA Recall Z-1074-2022 · Posted None
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Recalling FirmDaavlin Distributing Company
Recall StatusOpen, Classified
Product CodeFTC
Date Initiated2022-04-26
Product Quantity1
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.
Firm Action
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.
Root Cause
Software Design Change
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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