Cl II Viewray Treatment Planning software

Company:Viewray Incorporated
Date of Enforcement Report: 7/8/2015
Class lI:

PRODUCT

Treatment Planning and Delivery System Software version 3.6. ViewRay” Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Recall Number Z-1954-2015

REASON
The firm discovered that the software was failing to determine new patient locations if imaging is not enable during treatment.

RECALLING FIRM/MANUFACTURER
Viewray Incorporated, Oakwood Village, OH on 5/7/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
Distributed in the states of CA, MO & WI.

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.