Medium RiskFDA Device

Biodex Medical Systems, Inc.: 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

Agency Publication Date: September 27, 2021

Affected Products

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

Serial Number range:17081557-21062362 UDI: 00718175003305

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

Serial Number Range:17080651-21061047 UDI: 00718175003329

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88604

Status: Resolved

Manufacturer: Biodex Medical Systems, Inc.

Manufactured In: United States

Units Affected: 2 products (829 units; 429 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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