Recall Z-1459-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
| Date | Aug 2, 2008 (initiated Jan 30, 2008) |
| Status | Terminated |
| Reason | Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient. |
| Root cause | Software design |
| Action | Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution. |
| Quantity | 3 units subject to correction |
| Distribution | Nationwide Distribution including states of NC, FL and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) Varian Medical Systems, Aug 15, 2007 |