Recall Z-2195-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.
| Date | Sep 16, 2008 (initiated May 29, 2008) |
| Status | Terminated |
| Reason | Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area. |
| Root cause | Labeling False and Misleading |
| Action | Recall was initiated by the firm on 05/29/2008. A product notification letter /field safety letter was distributed to all affected users, with a description of the problem and user corrective action steps. In addition, the letter will also be distributed to Varian Sales, Marketing and Service Organizations. Letters were sent to consignees via certified mail with return receipt mailing to US consignees. For foreign consignees, letters will be translated as necessary and distributed with return proof of notification. Varian Medical can be contacted at 1-650-483-3153 for assistance. |
| Quantity | 182 |
| Distribution | Product was distributed throughout the US and to Australia, Brazil, Chile, France, Germany, Hong Kong, India, Israel, Japan, China, Malaysia, Russian Federation, Singapore and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962792 | LINAC SCALPEL TREATMENT PLANNING SYSTEM Surgical Navigation Technologies, Inc., Nov 12, 1996 |