Recall Z-2153-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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 t
| Date | Aug 8, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. |
| Root cause | Software design |
| Action | Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your |
| Quantity | 2 Units. |
| Distribution | Nationwide Distribution including the states of New York and Ohio. |
| 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 |