Recall Z-0713-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatm
| Date | Jan 11, 2012 (initiated Dec 16, 2011) |
| Status | Terminated |
| Reason | Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation. |
| Root cause | Under Investigation by firm |
| Action | Varian sent an "Urgent Medical Device Correction - Urgent Field Safety Notice" letter dated December 16, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, problem and recommended user actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medica |
| Quantity | 2235 units***12-12-12 AMENDED TO: 2984 units*** |
| Distribution | Worldwide Distribution - USA (nationwide) |
| 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 |