device · product 1 of 2
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
- Initiated
- April 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Daavlin Distributing Company
- Quantity
- 216
App-derived interpretation
Software issue
Official device-enrichment evidence · Sourced
Software Design Change
Inspect official wording and provenance
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.
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.
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.