Daavlin recalls 4 Series CX phototherapy units with specific software versions due to risk of incorrect dosing from treatment interruptions. Affected units have ClearLink Control System software v3.03h or v3.04v.
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.
Daavlin is recalling 4 Series CX phototherapy units with ClearLink Control System software versions v3.03h and v3.04v. These units may deliver incorrect dosing if treatment is interrupted, potentially affecting patient safety.
The software issue causes the phototherapy unit to swap calibration treatment distance from 0 inches to 9 inches when treatment is interrupted. This can lead to over or under dosing of light therapy, which may harm infants' skin health.
Parents or caregivers of infants using Daavlin 4 Series CX phototherapy units with specific software versions are most at risk. The recall affects units sold with ClearLink Control System software v3.03h or v3.04v.
Check for ClearLink Control System software versions v3.03h or v3.04v on your Daavlin 4 Series CX phototherapy unit. Affected units have serial numbers starting with QS11571PLNBCX0020.
Review your ClearLink Control System software version to confirm if it is v3.03h or v3.04v.
Daavlin will provide a software update to fix the issue; follow instructions from the manufacturer.
The software issue causes the phototherapy unit to swap calibration treatment distance from 0 inches to 9 inches when treatment is interrupted, leading to over or under dosing of light therapy.
Check for ClearLink Control System software versions v3.03h or v3.04v. Affected units have serial numbers starting with QS11571PLNBCX0020.
Daavlin will provide a software update to fix the issue; follow instructions from the manufacturer.
We’ve drafted a message you can send Daavlin to request your refund or repair — edit it as you like.
Subject: Recall Z-1074-2022 — Daavlin Daavlin Hello, I own a Daavlin that is covered by recall Z-1074-2022 from Daavlin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
