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U.S. Department of Health and Human Services

Class 2 Device Recall 4 Series Phototherapy Unit

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  Class 2 Device Recall 4 Series Phototherapy Unit see related information
Date Initiated by Firm April 26, 2022
Create Date May 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1074-2022
Recall Event ID 89990
510(K)Number K111172  
Product Classification Light, ultraviolet, dermatological - Product Code FTC
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.
Code Information UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
Recalling Firm/
Manufacturer		 Daavlin Distributing Company
205 W Bement St
Bryan OH 43506-1264
For Additional Information Contact
800-322-8546
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
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.
Quantity in Commerce 1
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FTC and Original Applicant = DAAVLIN DISTRIBUTING CO.
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