medical Class II Updated 2021-10-06

Biodex Medical Systems, Inc. recalls Atomlab 500 Dose Calibrator Software 2.0.00 through Revision

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number range:17081557-21062362 UDI: 00718175003305
View official government recall

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