Recall Z-0942-2022 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Imaging Laboratory GmbH
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
| Date | Mar 21, 2022 |
| Status | Completed |
| Reason | Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location |
| Root cause | Software Design Change |
| Action | On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions: Please retain a copy of this document along with your most current product labeling. Advise the appropriate personnel working in your radiotherapy department of the content of this letter. This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. Please complete the attached Return Response form provided. Kindly r |
| Quantity | 14 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China. |
| FDA record | Open on fda.gov |