FDA Enforcement
Class II
Ongoing
myQA iON; Article Number: MQ10-000;
Recall: Z-1703-2025
·
Reported May 7, 2025
Enforcement
- Recall Number
- Z-1703-2025
- Event ID
- 96647
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- IBA Dosimetry GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 7, 2025
- Initiation Date
- April 1, 2025
- Classification Date
- April 30, 2025
- Address
- Bahnhofstr. 5, Schwarzenbruck, N/A, Germany
Description
myQA iON; Article Number: MQ10-000;
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 Info
Article Number: MQ10-000; UDI-DI: EIBAMQ010000;
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.
Quantity
84 units (9US, 75 OUS)