Recall Z-0736-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan ext
| Date | Jan 13, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| Reason | An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse. |
| Root cause | Software design |
| Action | Varian Medical Systems sent a Urgent Medical Device Correction letter dated December 12, 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 the problem and the action needed to be taken by the customer. Customers were instructed to pay careful attention to any warnings displayed regarding the Virtual Collimator Jaws when the plan is calculated. If the warning indicates that the Virtual Collimator Jaws are inside the MLC apert |
| Quantity | 11807 units, ***12-12-12 Amended to: 13, 616 units*** |
| Distribution | Class II Recall - Worldwide Distribution -- USA (nationwide) including the countries of Canada and Europe. |
| 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 |