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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 01, 2003
Date Posted July 30, 2004
Recall Status1 Terminated 3 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.
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 2		 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.
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