Z-1251-2019 Class II Terminated
FDA device recall Z-1251-2019 was initiated by Viewray, Inc. on March 18, 2019 and is designated Class II. Reason for recall: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. The recall status is terminated (terminated June 16, 2022). Affected quantity: 17 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- March 18, 2019
- Termination Date
- June 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 devices
Product Description
MRIdian Linac Radiation Therapy System, Model 20000.
Reason for Recall
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Distribution Pattern
Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
Code Information
Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.