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U.S. Department of Health and Human Services

Class 2 Device Recall myQA iON

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 Class 2 Device Recall myQA iONsee related information
Date Initiated by FirmApril 01, 2025
Date PostedApril 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1703-2025
Recall Event ID 96647
510(K)NumberK201798 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductmyQA iON; Article Number: MQ10-000;
Code Information Article Number: MQ10-000; UDI-DI: EIBAMQ010000;
Recalling Firm/
Manufacturer		 IBA Dosimetry GmbH
Bahnhofstr. 5
Schwarzenbruck Germany
Manufacturer 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 2		Software design
ActionOn 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
Quantity in Commerce84 units (9US, 75 OUS)
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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