FDAClass IIJuly 22, 2015

Patient Handling System recall

Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions…

Why was Patient Handling System recalled?

ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.

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?

Model #10000, Serial #'s: 100, 101, and 102

Product
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions…
Recalling firm
Viewray Incorporated
Quantity
3
Distribution
US Nationwide Distribution in the states of CA, MO & WI
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls