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Atomlab 500 Plus 086-332Recalls & reported problems

Biodex Medical Systems, Inc. · Atomlab 500 Plus Dose Calibrator and Wipe Test System · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 16, 2021Terminated

    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

    Z-2581-2021 · Root cause: Software design · FDA record ↗

Other Calibrator, Dose, Radionuclide devices

All Calibrator, Dose, Radionuclide devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.