# FDA recall Z-2580-2021

> **Biodex Medical Systems, Inc.** · Class II · device recall initiated 2021-08-16.

## Product

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

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-2580-2021
- **Recalling firm:** Biodex Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-16
- **Report date:** 2021-10-06
- **Termination date:** 2024-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shirley, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2021

## Citation

> AI Analytics. FDA recall Z-2580-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2580-2021. Source: US FDA. Licensed CC0.

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