Recall Z-0836-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.
| Date | Dec 29, 2010 (initiated Mar 23, 2010) |
| Status | Terminated |
| Reason | Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue. |
| Root cause | Device Design |
| Action | Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated. Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated. Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning bef |
| Quantity | 218 units |
| Distribution | Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan |
| 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 |