Recall Z-2788-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malignant and benign diseases.
| Date | Jul 11, 2011 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. |
| Root cause | Software design |
| Action | Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail dated May 20, 2011, to all affected customers. ***12-20-12, 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, the problem, and the action to be taken by the customer. Customers were instructed to remove the product from use and advise users to manually initiate the configuration process for resampling to be applied when a previous calculation model is copied. Customers were asked to sign and re |
| Quantity | 10,356 |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102011 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Sep 3, 2010 |