Recall Z-2702-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
| Date | Jun 29, 2011 (initiated May 3, 2011) |
| Status | Terminated |
| Reason | In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc. Oncology Systems sent a "Urgent Medical Device Correction" letters on May 3, 2011 ***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 contained recommended actions. For additional information contact Varian Medical Systems, Inc. at 888- 827-4265. |
| Quantity | 5201 units ***12-12-12 AMENDED TO: 5448 units*** |
| Distribution | Worldwide distribution; Nationwide (USA) and the countries of Vietnam, Venezuela, United Kingdom, United Arab Emirates, Ukraine, Turkey, Tunisia, Trinidad and Tobago, Thailand, Taiwan, Syria, Switzerland, Sweden, Sri Lanka, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073020 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Dec 19, 2007 |