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Recall Observatory FDA recall evidence

Device product

myQA iON; Article Number: MQ10-000;

Z-1703-2025

April 01, 2025

Class II

Product summary

Firm
IBA Dosimetry GmbH
Event
Event 96647
Status
Ongoing
Classification
Class II
Quantity
84 units (9US, 75 OUS)
Official record key
device-enforcement:Z-1703-2025

Official wording

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

Code information: Article Number: MQ10-000; UDI-DI: EIBAMQ010000;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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