Recall Z-0531-2013— Varian Medical Systems, Inc. Oncology Systems
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-11-05, terminated 2014-03-03. It names one FDA 510(k) clearance: K093527. Product: Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. Reason: 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..
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-05
- Terminated
- 2014-03-03
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.