Company: Daavlin Distributing Company
Date of Enforcement Report: 5/18/2022
Class II
PRODUCT
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
Recall Number:
Z-1073-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
Daavlin Distributing Company on 5/18/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
216
DISTRIBUTION
U.S. Nationwide and International