Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 30, 2019
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only 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, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatm
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the wat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems, Inc. recalled Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm lic… - a moderate-severity action.
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm lic… was recalled by Varian Medical Systems, Inc. in January 30, 2019. Reason: There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PC…. Check the official notice for the remedy. Verify recall #Z-0771-2019 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. issued this moderate-severity FDA Devices recall-There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PC….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- January 30, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0771-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0771-2019) was formally reported on January 30, 2019, with the manufacturer initiating the action on December 26, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Varian Medical Systems, Inc. is listed as the recalling firm, operating out of Palo Alto, CA. Federal records list the affected scope as 1450 devices.
The documented reason for this recall is: There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) and countries of: Australia, Brazil, Denmark France, Germany, Japan, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan, and…. 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
1450 devices
Related Recalls
6
3 from same agency
Product description
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only 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, elec- tron 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
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0771-2019 |
| Date reported | January 30, 2019 |
| Date initiated | December 26, 2018 |
| Recalling firm | Varian Medical Systems, Inc. |
| Firm location | Palo Alto, CA |
| Affected scope | 1450 devices |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Australia, Brazil, Denmark France, Germany, Japan, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan, and United Kingdom. |
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-0771-2019) 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? ▼
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only 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, elec- tron 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.. Units affected: 1450 devices.
Why was this product recalled? ▼
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2019. Severity: Moderate. Recall number: Z-0771-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) and countries of: Australia, Brazil, Denmark France, Germany, Japan, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0771-2019) 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 January 30, 2019. 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.