Date Initiated by Firm | January 30, 2008 |
Date Posted | August 02, 2008 |
Recall Status1 |
Terminated 3 on August 18, 2010 |
Recall Number | Z-1459-2008 |
Recall Event ID |
46852 |
510(K)Number | K071992 |
Product Classification |
Medical charged-particle radiation therapy system - Product Code IYE
|
Product | High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator. |
Code Information |
Serial Number 1009. |
Recalling Firm/ Manufacturer |
Varian Medical Systems Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
|
For Additional Information Contact | 650-424-5731 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 3 units subject to correction |
Distribution | Nationwide Distribution including states of NC, FL and CA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = IYE
|