FDA Device recall Z-2580-2021
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330 by Biodex Medical Systems, citing 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 incor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2580-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-16 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biodex Medical Systems |
| Distribution | US |
Product
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
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
Identifiers
| code_info | Serial Number range:17081557-21062362 UDI: 00718175003305 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2021%22
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