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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 30, 2019. Severity: Moderate. Recall number: Z-0771-2019.

Q: 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..

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.

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…

Recall #: Z-0771-2019
Affected scope: 1450 devices
Initiated: December 26, 2018

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

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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 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

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

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-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.

Scale of Impact

1450 devices 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-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? ▼

Why was this product recalled? ▼

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..

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.

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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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This recall: FDA Devices, reported January 30, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026