ModerateClass IITerminated

FDA Devices recall · Reported January 18, 2017

Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: 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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0990-2017.

Q: Where was the recalled product distributed?

Distribution: US Distribution to the states of : NJ, TN. OR and FL..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0990-2017) 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.

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.

Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning Syst…

Recall #: Z-0990-2017
Affected scope: 42 devices are affected
Initiated: December 2, 2016

Compiled from official public sources by the editorial team. · Updated July 2026

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Varian Medical Systems, Inc. recalled Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowl… - a moderate-severity action.

Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowl… was recalled by Varian Medical Systems, Inc. in January 18, 2017. Reason: Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in con…. Check the official notice for the remedy. Verify recall #Z-0990-2017 with the FDA Devices before acting.

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The recall

Varian Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in con….

Moderate
severity level: 42 units
affected scope: Class II
classification: January 18, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0990-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0990-2017) was formally reported on January 18, 2017, with the manufacturer initiating the action on December 2, 2016. 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 42 devices are affected.

The documented reason for this recall is: Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain con… Distribution data in the federal record shows the product reached: US Distribution to the states of : NJ, TN. OR and FL.. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

42 devices are affected

Related Recalls

3 from same agency

Product description

Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: 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.

Reason for recall

Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.

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-0990-2017
Date reported	January 18, 2017
Date initiated	December 2, 2016
Recalling firm	Varian Medical Systems, Inc.
Firm location	Palo Alto, CA
Affected scope	42 devices are affected
Distribution	US Distribution to the states of : NJ, TN. OR and FL.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

42 devices are affected 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-0990-2017) 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 18, 2017. Severity: Moderate. Recall number: Z-0990-2017.

Where was the recalled product distributed? ▼

Distribution: US Distribution to the states of : NJ, TN. OR and FL..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0990-2017) 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 18, 2017. 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.