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