FDA-Device2025-05-07Class II
myQA iON; Article Number: MQ10-000;
IBA Dosimetry GmbH
Hazard
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Sold states
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.
Affected count
84 units (9US, 75 OUS)
Manufactured in
Bahnhofstr. 5, N/A, Schwarzenbruck, N/A, Germany
Products
myQA iON; Article Number: MQ10-000;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2025Don't want to check this manually?
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