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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-1233-04
Recall Event ID 29387
Product Classification Light, Ultraviolet, Dermatological - Product Code FTC
Product 3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424.
Code Information All Touch Control System, Model #PASNBSM-2424 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 2 units distributed domestically.
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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