Daavlin Distributing Company Recalls

FDA
2
Total Recalls
1
Agencies
Jul 2007
First Recall
May 2022
Latest Recall

Showing 1-2 of 2 recalls

FDA

1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Beginning April 26, 2022 Daavlin Distributing Co. is sent a recall notification letter via certified mail to customers. Customers are to acknowledge receipt of the notification and a company representative will call customers to arrange for return of the devices to update software. If you have any questions or concerns, contact the company at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, EST.

FDA

3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424.

Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.

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