FDA Devices recall · Reported May 22, 2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interloc…
Varian Medical Systems, Inc. Oncology Systems recalled Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Nu… - a moderate-severity action.
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Nu… was recalled by Varian Medical Systems, Inc. Oncology Systems in May 22, 2013. Reason: Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetr…. Check the official notice for the remedy. Verify recall #Z-1325-2013 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. Oncology Systems issued this moderate-severity FDA Devices recall-Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetr….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- May 22, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1325-2013 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.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
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 High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1325-2013 |
| Date reported | May 22, 2013 |
| Date initiated | May 31, 2011 |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Firm location | Palo Alto, CA |
| Affected scope | 3943 units |
| Distribution | Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria, Canada, Chile, China, Columbia, Cyprus… |
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-1325-2013) 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.
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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.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026