myQA iON; Article Number: MQ10-000;

FDA device recall Z-1703-2025 · posted 2025-04-30 · Open, Classified

Recall details

Recalling firm

IBA Dosimetry GmbH

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.

Action taken

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 service-usa@iba-group.com service-emea@iba-group.com service-apac@iba-group.com

Root cause

Software design

Status

Open, Classified

Product code

IYE

Quantity 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, No

Date initiated

2025-04-01

Date posted

2025-04-30

Location

Schwarzenbruck, Germany

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