myQA iON; Article Number: MQ10-000;
FDA Recall #Z-1703-2025 — Class II — April 1, 2025
Product Description
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.
Recalling Firm
IBA Dosimetry GmbH — Schwarzenbruck, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
84 units (9US, 75 OUS)
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, FL, GA, KS, MD, OK and the countries of Algeria, Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Morocco, Norway, Poland, Slovakia, Spain, Israel, Kazakhstan, Kosovo, Libya, South Africa, Turkey, United Kingdom, Switzerland, Argentina, Brazil, Mexico, APAC: Indonesia, Japan, Peoples Republic of China, Philippines, South Korea, Thailand.
Code Information
Article Number: MQ10-000; UDI-DI: EIBAMQ010000;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.