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Biodex Medical Systems Recalls
2 recalls on record · October 6, 2021 to October 6, 2021 · Medical Devices
October 6, 2021Medical DevicesFDA
Biodex Medical Systems, Inc. recalls AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Hazard: 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
October 6, 2021Medical DevicesFDA
Biodex Medical Systems, Inc. recalls Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Hazard: 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