Recall Z-1234-04 ยท FTC Light, Ultraviolet, Dermatological
Daavlin Distributing Company
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch Control System, Model #ASNBSM-2424 units manufactured between 6/5/03 and 4/30/04..
| Date | Jul 30, 2004 (initiated Sep 1, 2003) |
| Status | Terminated |
| Reason | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. |
| 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 | 12 units distributed domestically and 5 units distributed to foreign accounts. |
| Distribution | Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.