Mountain View, CA, United States
Viewray, Inc. recalls
5 recalls recorded since 2018, most recently on 4 May 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 May 2021
- Terminated
- 19 October 2023
- Reason
- Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
- Distribution
- International distribution only to the countries of France, Germany, Italy, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1836-2021
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision rad
Terminated Class II Medical devices
- Recall started
- 20 October 2020
- Terminated
- 13 October 2023
- Reason
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0481-2021, Z-0482-2021
- ViewRay MRIdian System: Model No. 10000, 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 ma
- 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, wit
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 22 February 2023
- Reason
- Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
- Distribution
- Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1803-2020
- ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Terminated Class II Medical devices
- Recall started
- 18 March 2019
- Terminated
- 16 June 2022
- Reason
- A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1251-2019
- MRIdian Linac Radiation Therapy System, Model 20000.
Terminated Class II Medical devices
- Recall started
- 3 March 2019
- Terminated
- 28 April 2021
- Reason
- Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
- Distribution
- US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0676-2020
- MRIdian Linac Radiation Therapy System Model 10000 and 20000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.