Z-2580-2021Class II

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330

Name: Z-2580-2021 Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330
Creator: Biodex Medical Systems, Inc.
Published: 2021-08-16
License: https://open.fda.gov/license/

Sport Medical Technology Inc / initiated 2021-08-16 / Terminated / root cause: software

FDA source

Biodex Medical Systems, Inc. began a recall of Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330 on 2021-08-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2580-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-16
Posted: 2021-09-27
Terminated: 2024-05-30
Recalling firm: Sport Medical Technology Inc
Product: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Product code: KPT Calibrator, Dose, Radionuclide
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: Biodex issued Urgent Medical Deice Recall Letter on 8/16/21 via email. Letter states reason for recall, health risk and action to take: Review the dial settings associated with custom isotope and confirm they have not been changed. Compare the measured activity with a dose calibrator from another manufacturer The error can be immediately corrected by restarting the system. We recommend that you promptly download new software. The error is corrected in Software Revision 2.0.10. The corrected software upgrade is available as a download from the Biodex website at the following link Atomlab 500 Dose Calibrator Software Update v2.0.10 - Software Updates - Nuclear Medicine | Biodex. System registration is required for download. Please email us at [email protected] to acknowledge receipt of this letter and confirm commitment to download the software update. To minimize risk of illness or injury, please download the software correction, as soon as possible. If you have any questions or require any additional information, please contact [email protected].
Quantity in commerce: 829 units
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
Product codes and lots: Serial Number range:17081557-21062362 UDI: 00718175003305

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2580-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2580-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-27
Z-2581-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-27

Product code KPT

K090296Class IIAtomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336Biodex Medical Systems, Inc. / cleared 2009-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)