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
Take action
Contact the company
📍Recalling firmBiodex Medical Systems, Inc.20 Ramsey Rd · Shirley, NY 11967-4704
“Biodex Atomlab 500 Software Recalls: Incorrect Dose Measurements Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61933-biodex-atomlab-500-software-recalls-incorrect-dose-measurements-risk. Based on FDA recall #Z-2580-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2021%22&limit=1).
The FDA announced on August 16, 2021, that Biodex Medical Systems, Inc. is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a hazard involving incorrect dose measurements and potential misadministration. The agency issued recall number Z-2580-2021 for the voluntary Class II recall.
According to the FDA, when deleting a previously entered custom isotope, the software deletes the isotope but not the associated dial setting. This error may cause other stored custom isotopes to have incorrect dial settings, leading to an incorrect dose measurement and/or misadministration.
Context
GovInfoNow's records show that RayStation/RayPlan Software experienced recalls on November 28, 2025, for radiation dose calculation risks and errors. Boston Scientific recalled TheraSphere 360 Y-90 Software due to an anomaly on June 19, 2026.
How to tell if you have this one
Check if your software version is 2.0.00 through 2.0.08 (inclusive) with model number 086-330. Serial numbers range from 17081557 to 21062362.
Brand
Biodex
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela
Recall number
Product, codes & lots
Quantity
Z-2580-2021
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.; Serial Number range:17081557-21062362 UDI: 00718175003305
829 units
Z-2581-2021
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332; Serial Number Range:17080651-21061047 UDI: 00718175003329
429 units
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your software version is 2.0.00 through 2.0.08 inclusive with model 086-330.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2580-2021 (August 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2580-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.