Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1325-2013) was formally reported on May 22, 2013, with the manufacturer initiating the action on May 31, 2011. 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 3943 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Chi…. 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
3943 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Varian Medical Systems, Inc. Oncology Systems. Units affected: 3943 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2013. Severity: Moderate. Recall number: Z-1325-2013.
Where was the recalled product distributed? ▼
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, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Frances, French Polynesia, Georgia, Germany, Greece, Gaudaloupe, Gaum, Hong Kong, India, Indonesia, Ireland, Italy, Israel, Latvia, Lithuania, Luxemburg, Japan, Kazarhstan, Kuwait, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morroco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Phillipines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Syria, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezula, Vietnam, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1325-2013) 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 May 22, 2013. 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.