Data Foundry

Medical device recalls 2025

myQA iON — Class II medical device recall Z-1703-2025

Ongoing recall by IBA Dosimetry GmbH, reported 2025-05-07, distributed nationwide. Wrong analysis results can occur if the user creates two structures with the same name, except for one differi

Recall numberZ-1703-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIBA Dosimetry GmbH, Schwarzenbruck, Germany
Recall initiated2025-04-01
Classified2025-04-30
Reported by FDA2025-05-07
DistributedNationwide (US)
Countries outside the USAR, AT, BE, BR, CH, CN, CZ, DE, DK, DZ, ES, FR, GB, ID, IE, IL, IT, JP, KR, MA, MX, NO, PH, PL, SK, TH, TR, ZA

Product

myQA iON; Article Number: MQ10-000;

Reason for recall

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

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-1703-2025. 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.