FDA recall Z-0785-2021

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2020-12-10

Report date

2021-01-13

Termination date

2022-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0785-2021