The Recall Desk

Manufacturer

Biodex Medical Systems, Inc.

2 recalls in our database name Biodex Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-10-06

Of the 2 recalls from Biodex Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2581-2021·2021-10-06

    Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements

    AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.

    Product
    AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2021·2021-10-06

    Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

    Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

    Product
    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
    Category
    Medical Device
    Distribution
    Distributed nationwide