Biodex recalls AtomLab 500Plus Dose Calibrator software versions 2.0.00 to 2.0.08 (model 086-332) due to potential incorrect dose measurements from deleted isotopes. Affected units have serial numbers 17080651-21061047.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Biodex is recalling software versions 2.0.00 through 2.0.08 for the AtomLab 500Plus Dose Calibrator. This could lead to incorrect dose measurements if custom isotopes are deleted without updating dial settings. Users should update to a newer software version to avoid risks.
When a user deletes a custom isotope in the software, the dial settings for that isotope are not updated. This can cause other stored isotopes to have incorrect dial settings, potentially leading to wrong dose measurements or misadministration of radiation.
Healthcare professionals using the AtomLab 500Plus Dose Calibrator software versions 2.0.00 to 2.0.08 are likely affected. Those who regularly use custom isotopes in radiation therapy may be at higher risk.
Check for software versions 2.0.00 through 2.0.08 on the AtomLab 500Plus Dose Calibrator. Affected units have serial numbers from 17080651 to 21061047.
Install a newer software version to fix the issue with isotope settings.
Software versions 2.0.00 through 2.0.08 (inclusive) for the AtomLab 500Plus Dose Calibrator.
Check your software version and serial number. Affected units have serial numbers 17080651-21061047.
Update to a newer software version to prevent incorrect dose measurements.
We’ve drafted a message you can send Biodex to request your refund or repair — edit it as you like.
Subject: Recall Z-2581-2021 — Biodex Biodex Hello, I own a Biodex that is covered by recall Z-2581-2021 from Biodex. 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.
