Z-1954-2015 Class II Terminated
FDA device recall Z-1954-2015 was initiated by Viewray Incorporated on May 7, 2015 and is designated Class II. Reason for recall: The software was failing to determine new patient locations if imaging is not enabled during treatment. The recall status is terminated (terminated February 4, 2016). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- May 7, 2015
- Termination Date
- February 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
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.
Reason for Recall
The software was failing to determine new patient locations if imaging is not enabled during treatment.
Distribution Pattern
Distributed in the states of CA, MO & WI.
Code Information
Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102