FDA Medical Device Recalls (openFDA)
Biodex Medical Systems, Inc.: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- Recall number
- Z-2580-2021
- Recalling firm
- Biodex Medical Systems, Inc.
- Product
- Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- Status
- Terminated
- Initiated
- 2021-08-16
- Posted
- not on file
- Terminated
- 2024-05-30
- 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
- Root cause
- Software design
- Action
- Biodex issued Urgent Medical Deice Recall Letter on 8/16/21 via email. Letter states reason for recall, health risk and action to take: Review the dial settings associated with custom isotope and confirm they have not been changed. Compare the measured activity with a dose calibrator from another manufacturer The error can be immediately corrected by restarting the system. We recommend that you promptly download new software. The error is corrected in Software Revision 2.0.10. The corrected software upgrade is available as a download from the Biodex website at the following link Atomlab 500 Dose Calibrator Software Update v2.0.10 - Software Updates - Nuclear Medicine | Biodex. System registration is required for download. Please email us at supportservices@biodex.com to acknowledge receipt of this letter and confirm commitment to download the software update. To minimize risk of illness or injury, please download the software correction, as soon as possible. If you have any questions or require any additional information, please contact supportservices@biodex.com.
- Quantity
- 829 units
- 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
- Lot, serial or model codes
- Serial Number range:17081557-21062362 UDI: 00718175003305
- 510(k) numbers
- ["K090296"]
- PMA numbers
- not on file
- Product code
- KPT
- Firm FEI
- 2431314
- Firm city
- Shirley
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28