Z-0482-2021Class II

ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range...

Name: Z-0482-2021 ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range...
Creator: Viewray, Inc.
Published: 2020-10-20
License: https://open.fda.gov/license/

Viewray, Inc. / initiated 2020-10-20 / Terminated / root cause: design

FDA source

Viewray, Inc. began a recall of ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A... on 2020-10-20. FDA classified it as Class II and gives the reason as "There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0482-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-20
Posted: 2020-11-20
Terminated: 2023-10-13
Recalling firm: Viewray, Inc.
Product: ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/20/2020, the firm, ViewRay, Inc, emailed an "Urgent Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm asked consignees to take the following actions.: 1. For Customer using TPDS software ver. 5.2.5 or earlier with optional 3 Plane imaging: - Do: Maintain a distance of at least 5 cm (~2) between the receive coil and the inner surface of the bore wall when using 3 Plane cin treatment imaging (Figure 3 & 4). - Do Not: Select 3 Plane cin treatment imaging if a distance of at least 5 cm (~2) cannot be maintained between the receive coil and the inner surface of the bore wall during treatment. 2. For Customer Using TPDS software ver. 5.3 or later with optional 8 fps enabled: - Do Not: Use 8 fps cin treatment imaging until further guidance is provided by ViewRay. - Do: Use 4 fps cin treatment imaging when treating a patient. 3. If you have any questions related to this letter, please contact ViewRay Customer Support at [email protected] or call +1 855-286-8875.
Quantity in commerce: 35 units
Distribution: Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.
Product codes and lots: All Lots/Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20
Z-0482-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)