FDA recall Z-1272-2021

Accuray Incorporated · Class II · device

Product

CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Reason for recall

The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ. CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV, PR and the countries of Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Republic of Korea, Latvia, Luxembourg, Malaysia, Mexico, Oman, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Key facts

Status
Terminated
Initiation date
2021-02-26
Report date
2021-03-24
Termination date
2022-06-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2021