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Terminated

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.

FDA Recall Z-1272-2021 · Posted None

Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-02-26
Date Terminated2022-06-27
Product Quantity243 units

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.

Firm Action

An URGENT FIELD SAFETY NOTICE will be delivered to customers beginning on 02/26/2021. Customers are asked to return a signed copy of the letter back to Accuray. Field Service Engineers will visit all impacted sites to perform a work instruction that includes the inspection of the set screws and verification of the integrity of the overall couch system, including the linkage arm and its connection to the roll motor. This work instruction will be performed on an annual basis. Customers may continue to use the STC and CyberKnife System. However, those who assist patients should provide extra care when individuals are getting on or off the STC.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170788CyberKnife Treatment Delivery SystemAccuray Incorportaed · 2017-04-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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