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.
Reported: March 24, 2021 Initiated: February 26, 2021 #Z-1272-2021
Product Description
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.
Details
- Recalling Firm
- Accuray Incorporated
- Units Affected
- 243 units
- 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.
- Location
- Madison, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accuray Incorporated. Units affected: 243 units.
Why was this product recalled? ▼
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1272-2021.
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