ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a t
FDA device recall Z-2763-2011 · posted 2011-07-08 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.
- Action taken
- Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 357
- Distribution
- Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong,
- Date initiated
- 2011-05-17
- Date posted
- 2011-07-08
- Date terminated
- 2012-03-15
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |