1 Series CX phototherapy units equipped with Daavlin's ClearLink… — Class II medical device recall Z-1073-2022
Ongoing recall by Daavlin Distributing Company, reported 2022-05-18, distributed nationwide. Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distan
| Recall number | Z-1073-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Daavlin Distributing Company, Bryan, OH, United States |
| Recall initiated | 2022-04-26 |
| Classified | 2022-05-12 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 216 |
| Reason classes | software |
| Serial numbers | OS20337PLNBCX0004, OS21997PLNBCX0004, OS22013PLNBCX0004, OS22015PLNBCX0004, OS22033PLNBCX0004, OS22049PLNBCX0004, OS22060PLNBCX0004, OS22062PLNBCX0004, OS22063PLNBCX0004, OS22075PLNBCX0004, OS22088PLNBCX0004, OS22090PLNBCX0004, OS22092PLNBCX0004, OS22097PLNBCX0004, OS22103PLACX0400, OS22106PLNBCX0004, OS22112PLNBCX0004, OS22154PLNBCX0004, OS22183PLNBCX0004, OS22200PLNBCX0004, OS22201PLNBCX0004, OS22227PLNBCX0004, OS22229PLNBCX0004, OS22258PLNBCX0004, OS22263PLNBCX0004 and 190 more |
| Model numbers | 120-240V, 305-4, 311-4, 350-4, 50/60HZ, 50/60HZCE, UVA1-4 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1073-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.