Recall Z-0867-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
| Date | Feb 20, 2013 (initiated Jan 28, 2013) |
| Status | Terminated |
| Reason | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc. Oncology Systems sent an Urgent Medical Device Correction Letter dated January 30, 2013 to all affected customers. The Letter identified the affected product, problem and actions to be taken. Varian Medical Systems is developing a technical correction for this issue, Its customers will be contacted by a Varian Customer Service representatives when this correction is available to schedule its installation. The letter provides customers with help desk contact information. |
| Quantity | 1168 units |
| 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 |