Recall Z-1703-2025

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.

FDA-determined cause: Software design

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