Z-2085-2015 Class II Terminated
FDA device recall Z-2085-2015 was initiated by Viewray Incorporated on April 1, 2015 and is designated Class II. Reason for recall: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. The recall status is terminated (terminated February 4, 2016). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- April 1, 2015
- Termination Date
- February 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for Recall
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Distribution Pattern
US Nationwide Distribution in the states of CA, MO & WI
Code Information
Model #10000, Serial #'s: 100, 101, and 102