Recall record at a glance
| Official record | Z-0482-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Viewray, Inc. |
| Report date | Dec 2, 2020 |
| Recall initiation date | Oct 20, 2020 |
| Quantity | 35 units |
| Location | Mountain View, CA, United States |
Official product description
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.
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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