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.
Reported: January 13, 2021 Initiated: December 10, 2020 #Z-0785-2021
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.
Details
- Recalling Firm
- Accuray Incorporated
- Units Affected
- 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.
- Location
- Madison, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accuray Incorporated. Units affected: 8 units.
Why was this product recalled? ▼
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0785-2021.
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