Recall Z-0531-2013 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
| Date | Dec 17, 2012 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import. |
| Root cause | Software design |
| Action | Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manag |
| Quantity | 264 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093527 | ARIA RADIATION ONCOLOGY WITH MIRS Varian Medical Systems, Inc., Dec 15, 2009 |