Z-0784-2021 Class II Terminated
FDA device recall Z-0784-2021 was initiated by Accuray Incorporated on December 10, 2020 and is designated Class II. Reason for recall: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. The recall status is terminated (terminated September 26, 2022). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 10, 2020
- Termination Date
- September 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
TomoTherapy Treatment System - 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.
Distribution Pattern
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: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468