Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2012
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Ecl
Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems, Inc. Oncology Systems recalled Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48… - a moderate-severity action.
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48… was recalled by Varian Medical Systems, Inc. Oncology Systems in July 25, 2012. Reason: Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where chan…. Check the official notice for the remedy. Verify recall #Z-2041-2012 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. Oncology Systems issued this moderate-severity FDA Devices recall-Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where chan….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2041-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2041-2012) was formally reported on July 25, 2012, with the manufacturer initiating the action on June 18, 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 7113 units.
The documented reason for this recall is: Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, Ind…. 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
7113 units
Related Recalls
6
3 from same agency
Product description
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Reason for recall
Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2041-2012 |
| Date reported | July 25, 2012 |
| Date initiated | June 18, 2012 |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Firm location | Palo Alto, CA |
| Affected scope | 7113 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israe… |
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-2041-2012) 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 Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.. Recalled by Varian Medical Systems, Inc. Oncology Systems. Units affected: 7113 units.
Why was this product recalled? ▼
Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2041-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2041-2012) 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 July 25, 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.