Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2012
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
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 fi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems, Inc. Oncology Systems recalled Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology… - a moderate-severity action.
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology… was recalled by Varian Medical Systems, Inc. Oncology Systems in December 26, 2012. Reason: Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology…. Check the official notice for the remedy. Verify recall #Z-0531-2013 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. Oncology Systems issued this moderate-severity FDA Devices recall-Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology….
- Moderate
- severity level
- 264 units
- affected scope
- Class II
- classification
- December 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0531-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0531-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on November 5, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Varian Medical Systems, Inc. Oncology Systems is listed as the recalling firm, operating out of Palo Alto, CA. Federal records list the affected scope as 264 units.
The documented reason for this recall is: 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 D… Distribution data in the federal record shows the product reached: Worldwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
264 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0531-2013 |
| Date reported | December 26, 2012 |
| Date initiated | November 5, 2012 |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Firm location | Palo Alto, CA |
| Affected scope | 264 units |
| Distribution | Worldwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0531-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Varian Medical Systems, Inc. Oncology Systems. Units affected: 264 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0531-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0531-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.