Daavlin recalls 1 Series CX phototherapy units with specific software versions that may cause incorrect light therapy dosing if treatment is interrupted.
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 certain 1 Series CX phototherapy units that have software versions v3.03h and v3.04v. If treatment is interrupted and resumed, the device may swap calibration settings to 0 inches or 9 inches, causing over or under dosing of light therapy.
The software issue causes the device to reset calibration distance to 0 inches or 9 inches when treatment is interrupted and resumed. This can lead to incorrect light therapy dosing, potentially causing jaundice to worsen or not treat properly.
Parents or caregivers using the phototherapy units for infants or children with jaundice are most at risk. The affected units have specific serial numbers and software versions listed in the recall notice.
Check if your 1 Series CX phototherapy unit has software versions v3.03h or v3.04v. Look for the specific serial numbers or model numbers listed in the recall notice, which include details about voltage and frequency.
Verify your device's software version by checking the ClearLink Control System settings.
Reach out to Daavlin Distributing Company for assistance with the recall or to get instructions on correcting the software issue.
Software versions v3.03h and v3.04v of the ClearLink Control System.
Check the serial numbers listed in the recall notice, which include specific models and item numbers like OS22183PLNBCX0004.
Contact Daavlin Distributing Company for instructions on correcting the software issue or getting a replacement.
We’ve drafted a message you can send Daavlin to request your refund or repair — edit it as you like.
Subject: Recall Z-1073-2022 — Daavlin Daavlin Hello, I own a Daavlin that is covered by recall Z-1073-2022 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.
