Company: Biodex Medical Systems, Inc.
Date of Enforcement Report: 10/6/2021
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Recall Number: Z-2580-2021
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.
Biodex Medical Systems, Inc. on 8/16/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
U.S. Nationwide and International