Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Mo
FDA device recall Z-0531-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
- Action taken
- Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. US and Canada 1-888-827-4265. For questions regarding this recall call 650-424-5731.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 264 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2012-11-05
- Date posted
- 2012-12-17
- Date terminated
- 2014-03-03
- 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 |
|---|---|---|
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |