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
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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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