Atomlab 500 Dose Calibrator Software 2.0.00 through… recallZ-2580-2021 · Biodex Medical Systems, Inc. · initiated Aug 16, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biodex Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software design
What the company is doing
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].
Recall details
- Recall number
- Z-2580-2021
- Status
- Terminated
- Initiated by the company
- Aug 16, 2021
- Recalling firm
- Biodex Medical Systems, Inc.
- Quantity
- 829 units
- Product code
- KPT
- FDA submissions
- K090296
- 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 description
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Code information (models, lots, serial numbers)
Serial Number range:17081557-21062362 UDI: 00718175003305
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atomlab 500 Dose Calibrator 086-330Biodex Medical Systems, Inc. · Calibrator, Dose, Radionuclide1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88604).
- Z-2581-2021 · TerminatedAtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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