CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report
1 Series CX phototherapy units equipped recalled by Daavlin Distributing
Daavlin Distributing is recalling 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System, distributed nationwide in the US. The recall was initiated on 26 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1073-2022
- FDA event ID
- 89990
- Recalling firm
- Daavlin Distributing, Bryan, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Apr 2022
- FDA classified
- 12 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 26 Apr 2022 | Recall initiated by company | |
| 12 May 2022 | Classified by FDA | +16 days |
| 18 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the 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]
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 89990| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 4 Series CX phototherapy units equipped recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
More recalls from Daavlin Distributing
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Photera 600, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | Photera 400, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | Photera 600 3-D, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | Phothera 200, Phototherapy Devices indicated recalled | Daavlin Distributing | Other | Nationwide |
| Device | CLASS II | 4 Series CX phototherapy units equipped recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
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| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |