Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 8, 2019
MRIdian Linac Radiation Therapy System, Model 20000.
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Viewray, Inc. recalled MRIdian Linac Radiation Therapy System, Model 20000. - a moderate-severity action.
MRIdian Linac Radiation Therapy System, Model 20000. was recalled by Viewray, Inc. in May 8, 2019. Reason: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and A…. Check the official notice for the remedy. Verify recall #Z-1251-2019 with the FDA Devices before acting.
The recall
Viewray, Inc. issued this moderate-severity FDA Devices recall-A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and A….
- Moderate
- severity level
- 17 units
- affected scope
- Class II
- classification
- May 8, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1251-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1251-2019) was formally reported on May 8, 2019, with the manufacturer initiating the action on March 18, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Viewray, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records list the affected scope as 17 devices.
The documented reason for this recall is: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. Distribution data in the federal record shows the product reached: Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,. 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, 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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.
Affected scope
17 devices
Related Recalls
6
6 from same agency
Product description
MRIdian Linac Radiation Therapy System, Model 20000.
Reason for recall
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1251-2019 |
| Date reported | May 8, 2019 |
| Date initiated | March 18, 2019 |
| Recalling firm | Viewray, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 17 devices |
| Distribution | Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE, |
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-1251-2019) 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? ▼
MRIdian Linac Radiation Therapy System, Model 20000.. Recalled by Viewray, Inc.. Units affected: 17 devices.
Why was this product recalled? ▼
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1251-2019.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1251-2019) 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 May 8, 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 August 2026.