Class II

Medical Device Recall: myQA iON; Article Number: MQ10-000;

IBA Dosimetry GmbH · April 1, 2025

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.

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.

States Affected

NATIONWIDE

Quantity Affected

84 units (9US, 75 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1703-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.