Device recall: MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian…
Class II FDA enforcement event 73550. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Viewray Incorporated started this device recall on 7 Mar 2016. The firm address in the FDA record is in Oakwood Village, OH. FDA put the recall in Class II. FDA event 73550 has 1 product record. The first FDA enforcement report date is 6 Apr 2016. The record gives the status Terminated, with the termination date 22 Feb 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
Recalling firm
Viewray Incorporated, Oakwood Village, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1309-2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated | 5 units | Class II | Terminated | 6 Apr 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Dec 2015 | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | Device | Class II | 1 |
| 27 Aug 2015 | MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy | Device | Class II | 1 |
| 7 May 2015 | Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precis | Device | Class II | 1 |
| 1 Apr 2015 | Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision | Device | Class II | 1 |
| 15 Jan 2015 | ViewRay System, Radiation Therapy System | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1309-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 73550. https://recallregister.com/fda/ii/73550/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
- What quantity of product is in FDA event 73550?
- The FDA record gives this quantity:
5 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.