IBA Dosimetry GmbH: Device Recall
Recall #Z-1703-2025 · 04/01/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1703-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- IBA Dosimetry GmbH
- Status
- Ongoing
- Date Initiated
- 04/01/2025
- Location
- Schwarzenbruck, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units (9US, 75 OUS)
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.
Product Description
myQA iON; Article Number: MQ10-000;
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.