FDA recall Z-1073-2022

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]

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.

Key facts

Status

Ongoing

Initiation date

2022-04-26

Report date

2022-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bryan, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1073-2022