AtomLab 500Plus Dose CalibratorSoftware 2 — Class II medical device recall Z-2581-2021
Terminated recall by Biodex Medical Systems, Inc., reported 2021-10-06, distributed nationwide. When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated di
| Recall number | Z-2581-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biodex Medical Systems, Inc., Shirley, NY, United States |
| Recall initiated | 2021-08-16 |
| Classified | 2021-09-27 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BR, CA, CL, CO, CY, CZ, DK, DO, EC, EG, ES, FR, GB, HK, HR, HU, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KW, LB, MA, MT, MX, MY, NL, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, TW, VE, ZA |
| Quantity | 429 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00718175003329 |
| Model numbers | 086-332 |
Product
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2581-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.