Medical device recalls Moderate risk

IBA Dosimetry GmbH recalls myQA iON; Article Number: MQ10-000;

Recall date
April 1, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1703-2025
FDA classification
Class II
Brand / firm
IBA Dosimetry GmbH
Sold / distributed
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 King…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

myQA iON; Article Number: MQ10-000;

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