High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Produ
FDA device recall Z-1459-2008 · posted 2008-08-02 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3 units subject to correction
- Distribution
- Nationwide Distribution including states of NC, FL and CA.
- Date initiated
- 2008-01-30
- Date posted
- 2008-08-02
- Date terminated
- 2010-08-18
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) (K071992) | Varian Medical Systems | 2007-08-15 |