ViewRay MRIdian System recall
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…
Why was ViewRay MRIdian System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots/Serial Numbers
- 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…
- Recalling firm
- Viewray, Inc.
- Quantity
- 3 systems
- 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.
- Recall date
- December 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)