ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The ARIA Radiation Oncology product is a treatment
FDA device recall Z-1905-2011 · posted 2011-04-07 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.
- Action taken
- Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items. For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265. Europe +41 41 749 8844
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 645
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Fi
- Date initiated
- 2011-02-18
- Date posted
- 2011-04-07
- Date terminated
- 2012-06-19
- 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 |