Biodex Medical Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2580-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 16, 2021

Date Posted: October 6, 2021

Recall Number: Z-2580-2021

Event ID: 88604

Reason for Recall:

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

Status: Terminated

Product Quantity: 829 units

Code Information:

Serial Number range:17081557-21062362 UDI: 00718175003305

Distribution Pattern:

Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela

Voluntary or Mandated:

Voluntary: Firm initiated