TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for...
FDA Recall #Z-0785-2021 — Class II — December 10, 2020
Product Description
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Reason for Recall
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Recalling Firm
Accuray Incorporated — Madison, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.
Code Information
Product Codes: 104430, 1018286, H-0000-0003, 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated