Z-0115-2016 Class II Terminated
FDA device recall Z-0115-2016 was initiated by Viewray Incorporated on August 27, 2015 and is designated Class II. Reason for recall: ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. The recall status is terminated (terminated June 9, 2017). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2015
- Initiation Date
- August 27, 2015
- Termination Date
- June 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is 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 discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Distribution Pattern
US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Code Information
Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105