Z-1073-2022 Class II Ongoing

Recalled by Daavlin Distributing Company — Bryan, OH

Recall Details

Product Type
Devices
Report Date
May 18, 2022
Initiation Date
April 26, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
216

Product Description

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 Pattern

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.

Code Information

UDI-DI: +B2809806OS0004CX60K, +B2809807OS0004CX50K, +B2809807OS0004CX60L, +B2809807OS0400CX60L, and +B2809807OS0400CX6A10W. Serial Numbers: OS22183PLNBCX0004, OS22320PLNBCX0004, OS23725PLNBCX0004, OS24083PLNBCX0004, OS24089PLNBCX0004, OS24090PLNBCX0004, OS23532PLA1CX0400, OS22097PLNBCX0004, OS22200PLNBCX0004, OS22265PLNBCX0004, OS22270PLNBCX0004, OS22304PLNBCX0004, OS22739PLNBCX0004, OS22788PLNBCX0004, OS22795PLNBCX0004, OS23239PLNBCX0004, OS23609PLNBCX0004, OS23894PLNBCX0004, OS24017PLNBCX0004, OS24254PLNBCX0004, OS24810PLNBCX0004, OS21997PLNBCX0004, OS22060PLNBCX0004, OS22063PLNBCX0004, OS22273PLNBCX0004, OS22309PLNBCX0004, OS22637PLNBCX0004, OS22680PLNBCX0004, OS22736PLNBCX0004, OS22738PLNBCX0004, OS22770PLNBCX0004, OS22789PLNBCX0004, OS22796PLNBCX0004, OS22919PLNBCX0004, OS22977PLNBCX0004, OS22980PLNBCX0004, OS22983PLNBCX0004, OS23244PLNBCX0004, OS23252PLNBCX0004, OS23440PLNBCX0004, OS23681PLNBCX0004, OS23724PLNBCX0004, OS23762PLNBCX0004, OS23855PLNBCX0004, OS23856PLNBCX0004, OS24008PLNBCX0004, OS24077PLNBCX0004, OS24104PLNBCX0004, OS24107PLNBCX0004, OS24109PLNBCX0004, OS24113PLACX0400, OS24127PLNBCX0004, OS24308PLNBCX0004, OS24310PLNBCX0004, OS24376PLNBCX0004, OS24467PLNBCX0004, OS24478PLNBCX0004, OS24229PLACX0400, OS22663PLNBCX0004, OS23940PLNBCX0004, OS23461PLNBCX0004, OS24829PLNBCX0004, OS22154PLNBCX0004, OS22112PLNBCX0004, OS22537PLNBCX0004, OS22271PLNBCX0004, OS24078PLNBCX0004, OS22227PLNBCX0004, OS23274PLNBCX0004, OS23481PLNBCX0004, OS23525PLNBCX0004, OS23676PLNBCX0004, OS23711PLNBCX0004, OS23910PLNBCX0004, OS24296PLNBCX0004, OS24325PLNBCX0004, OS24345PLNBCX0004, OS24358PLNBCX0004, OS24828PLNBCX0004, OS22794PLNBCX0004, OS24479PLNBCX0004, OS24682PLNBCX0004, OS24760PLNBCX0004, OS24228PLNBCX0004, OS24857PLNBCX0004, OS22033PLNBCX0004, OS22293PLNBCX0004, OS23526PLNBCX0004, OS23866PLNBCX0004, OS23896PLNBCX0004, OS24500PLNBCX0004, OS22439PLNBCX0004, OS22641PLNBCX0004, OS22766PLNBCX0004, OS23502PLNBCX0004, OS23941PLNBCX0004, OS24110PLNBCX0004, OS22015PLNBCX0004, OS22452PLNBCX0004, OS22453PLNBCX0004, OS24020PLNBCX0004, OS24680PLNBCX0004, OS22090PLNBCX0004, OS22266PLNBCX0004, OS22442PLNBCX0004, OS22633PLNBCX0004, OS22640PLNBCX0004, OS22764PLNBCX0004, OS23233PLNBCX0004, OS23255PLNBCX0004, OS23496PLNBCX0004, OS23527PLNBCX0004, OS23528PLNBCX0004, OS23873PLNBCX0004, OS23911PLNBCX0004, OS23961PLNBCX0004, OS24082PLNBCX0004, OS24105PLNBCX0004, OS24132PLNBCX0004, OS24211PLNBCX0004, OS22716PLACX0400, OS22717PLBBCX0004, OS23353PLACX0400, OS23354PLACX0400, OS23352PLACX0400, OS23355PLBBCX0004, OS22103PLACX0400, OS22062PLNBCX0004, OS22258PLNBCX0004, OS22229PLNBCX0004, OS22818PLNBCX0004, OS22869PLA1CX0400, OS23253PLNBCX0004, OS24051PLNBCX0004, OS24281PLNBCX0004, OS24422PLNBCX0004, OS24423PLNBCX0004, OS23183PLNBCX0004, OS22013PLNBCX0004, OS22049PLNBCX0004, OS22075PLNBCX0004, OS22088PLNBCX0004, OS22092PLNBCX0004, OS22106PLNBCX0004, OS22263PLNBCX0004, OS22269PLNBCX0004, OS22308PLNBCX0004, OS22397PLNBCX0004, OS22440PLNBCX0004, OS22441PLNBCX0004, OS22502PLA1CX0400, OS22635PLNBCX0004, OS22643PLNBCX0004, OS22681PLNBCX0004, OS22741PLNBCX0004, OS22762PLNBCX0004, OS22763PLNBCX0004, OS22765PLNBCX0004, OS22769PLNBCX0004, OS22791PLNBCX0004, OS22812PLNBCX0004, OS22822PLNBCX0004, OS22917PLNBCX0004, OS22918PLNBCX0004, OS23049PLNBCX0004, OS23053PLNBCX0004, OS23061PLNBCX0004, OS23101PLNBCX0004, OS23237PLNBCX0004, OS23240PLNBCX0004, OS23241PLNBCX0004, OS23243PLNBCX0004, OS23246PLNBCX0004, OS23254PLNBCX0004, OS23272PLNBCX0004, OS23418PLNBCX0004, OS23463PLNBCX0004, OS23466PLNBCX0004, OS23470PLNBCX0004, OS23474PLA1CX0400, OS23480PLNBCX0004, OS23529PLNBCX0004, OS23530PLNBCX0004, OS23569PLNBCX0004, OS23620PLNBCX0004, OS23675PLNBCX0004, OS23756PLNBCX0004, OS23857PLNBCX0004, OS23867PLNBCX0004, OS23890PLNBCX0004, OS23898PLNBCX0004, OS23909PLNBCX0004, OS24106PLNBCX0004, OS24166PLNBCX0004, OS24168PLA1CX0400, OS24227PLNBCX0004, OS24312PLNBCX0004, OS24539PLNBCX0004, OS24630PLNBCX0004, OS24743PLNBCX0004, OS24789PLNBCX0004, OS24791PLNBCX0004, OS24811PLNBCX0004, OS23940PLNBCX0004, OS22777PLNBCX0004, OS22778PLNBCX0004, OS20337PLNBCX0004, OS22201PLNBCX0004, OS22303PLNBCX0004, OS22334PLNBCX0004, OS22612PLNBCX0004, OS22871PLNBCX0004, OS22873PLNBCX0004, OS23086PLNBCX0004, OS23189PLNBCX0004, OS24421PLNBCX0004.