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Terminated

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

FDA Recall Z-2581-2021 · Posted None

Recall StatusTerminated
Product CodeKPT
Date Initiated2021-08-16
Date Terminated2024-05-30
Product Quantity429 units

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

Firm 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].

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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