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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0531-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution.

Q: 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.

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…

Recall #: Z-0531-2013
Affected scope: 264 units
Initiated: November 5, 2012

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Devices recall record
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.

Scale of Impact

264 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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? ▼

Why was this product recalled? ▼

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.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

American Honda Expands Recall of FourTrax… 2012-12-26 Bethlehem Lights Recalls Christmas Trees … 2012-12-26 Procrit (epoetin alfa) injection, 20000 u… 2012-12-26 Nalbuphine HCl Injection, 20 mg/mL, 10 mL… 2012-12-26

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Choletec - Kit for the Preparation of Tec… 2012-12-26 GE Healthcare, Dash 3000/4000/5000. Th… 2012-12-26 Patient Circuit used with the Life Pulse … 2012-12-26 GE Healthcare Carescape Patient Data Modu… 2012-12-26

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported December 26, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026