Class 2 Device Recall

• Date Initiated by Firm: September 01, 2003
• Date Posted: July 30, 2004
• Recall Status: Terminated on July 24, 2007
• Recall Number: Z-1236-04
• Recall Event ID: 29387
• Product Classification: Light, Ultraviolet, Dermatological - Product Code FTC
• Product: 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048.
• Code Information: All Touch Control System, Model #SNBSM-0048 units manufactured between 6/5/03 and 4/30/04.
• FEI Number: 1526255
• Recalling Firm/ Manufacturer: Daavlin Distributing Company; 205 West Bement Street; PO Box 626; Bryan OH 43506-0626
• For Additional Information Contact: David Swanson; 419-636-6304
• Manufacturer Reason for Recall: Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
• FDA Determined Cause: Other
• Action: The firm has software patches to correct the programming problems as they are reported by the users. These patches are being installed either by a service representative for the manufacturer or by the customer
• Quantity in Commerce: 23 units distributed domestically and 23 units distributed to foreign accounts.
• Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.