PlainRecalls
FDA Devices Moderate Class II Ongoing

myQA iON; Article Number: MQ10-000;

Reported: May 7, 2025 Initiated: April 1, 2025 #Z-1703-2025

Product Description

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.

Details

Recalling Firm
IBA Dosimetry GmbH
Units Affected
84 units (9US, 75 OUS)
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.
Location
Schwarzenbruck, N/A

Frequently Asked Questions

What product was recalled?
myQA iON; Article Number: MQ10-000;. Recalled by IBA Dosimetry GmbH. Units affected: 84 units (9US, 75 OUS).
Why was this product recalled?
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1703-2025.