Z-1703-2025Class II

myQA iON; Article Number: MQ10-000

Name: Z-1703-2025 myQA iON; Article Number: MQ10-000
Creator: IBA Dosimetry GmbH
Published: 2025-04-01
License: https://open.fda.gov/license/

IBA Dosimetry GmbH / initiated 2025-04-01 / Open, Classified / root cause: software

FDA source

IBA Dosimetry GmbH began a recall of myQA iON; Article Number: MQ10-000 on 2025-04-01. FDA classified it as Class II and gives the reason as "Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1703-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-01
Posted: 2025-04-30
Recalling firm: IBA Dosimetry GmbH
Product: myQA iON; Article Number: MQ10-000;
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: On April 1, 2025, FIELD SAFETY NOTICE letters were sent to customers. Actions to be taken to prevent the error from occurring: When naming structures, please refrain from using any of the following special characters: % \ / : * ? < > | + Additionally, during the export of files into myQA iON, some TPSs cut off the structure names due to their length. Users are not notified when names are automatically shortened by the system. Please check that the structure name was correctly imported. Distribution of this Field Safety Notice: Please distribute this notice to all those who need to be aware within your area of responsibility where the affected medical device is in use. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. Contact information: Please feel free to contact us as follows if you have any further questions: USA, Canada, Latin America Europe, Middle East, Africa Asia Pacific Phone: +1 786 288 0369 Phone: +49 9128 607 38 Phone: +65 3129 2472 [email protected] [email protected] [email protected]
Quantity in commerce: 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.
Product codes and lots: Article Number: MQ10-000; UDI-DI: EIBAMQ010000;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-30

Product code IYE

K201798Class IImyQA iONIba Dosimetry GmbH / cleared 2020-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)