FDA recall Z-1703-2025

IBA Dosimetry GmbH · Class II · device

Product

myQA iON; Article Number: MQ10-000;

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-04-01
Report date
2025-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Schwarzenbruck, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2025