Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1237-04

3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048

The Daavlin Distributing Co. / initiated 2003-09-01 / Terminated / root cause: software

Daavlin Distributing Company began a recall of 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048 on . The reason FDA records is "Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1237-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
The Daavlin Distributing Co.
Product
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048.
Product code
FTC Light, Ultraviolet, Dermatological
Reason for recall
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
Root cause tag
software
FDA root 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
1 unit distributed domestically.
Distribution
Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany
Product codes and lots
All Touch Control System, Model #ANBSM-0048 units manufactured between 6/5/03 and 4/30/04.