Recall – Software error leads to incorrect dose calibrator dial setting

Company: Biodex Medical Systems, Inc.
Date of Enforcement Report: 10/6/2021
Class II

PRODUCT

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

Recall Number: Z-2580-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Biodex Medical Systems, Inc. on 8/16/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

829 units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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