Recall Z-1703-2025 ยท IYE Accelerator, Linear, Medical
IBA Dosimetry GmbH
myQA iON; Article Number: MQ10-000;
| Date | Apr 30, 2025 (initiated Apr 1, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 w |
| Quantity | 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 Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201798 | myQA iON Iba Dosimetry GmbH, Jul 17, 2020 |