Z-1580-2015 Class II Terminated
FDA device recall Z-1580-2015 was initiated by Viewray Incorporated on January 15, 2015 and is designated Class II. Reason for recall: The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch… The recall status is terminated (terminated September 23, 2015). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- January 15, 2015
- Termination Date
- September 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
ViewRay System, Radiation Therapy System
Reason for Recall
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
Distribution Pattern
US distribution to MO.
Code Information
M/N 10000, S/N 100 only