The Recall Desk

FDA (Devices) recall action 86661

Viewray, Inc. recalled 2 products on 2020-12-02

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-02
Critical
0
Units
38

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-12-02

    ViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk

    Viewray, Inc. is recalling 35 ViewRay MRIdian Linac Systems because receive coil components may reach elevated temperatures, posing a risk of burn injury to patients or users.

    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 pr
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2020-12-02

    ViewRay MRIdian System Recalled for Potential Burn Injury Risk

    ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.

    Product
    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 magnetic resonance imaging capabilities, is intended to provid
    Category
    Distribution
    8 states