Accuray Incorporated

Complete recall history across all FDA and CPSC categories — 20 total recalls

Accuray Incorporated appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (20)

FDA medical device enforcement actions by Accuray Incorporated

Date Product Reason Class
Dec 23, 2024 CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System ma... Snap rings may become partially or completed detached from the shafts within ... Class II
Aug 3, 2023 Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for ... It is possible the upper roller bracket in the Radixact System gantry enclosu... Class II
Feb 26, 2021 CyberKnife Treatment Delivery System - Product Usage: indicated for image-gui... The set screws that connect the Standard Treatment Couch linkage arm to the r... Class II
Dec 10, 2020 TomoTherapy Treatment System - Product Usage: used as an integrated system fo... "MLC tickle error" may result in the delivered dose to effectively rotate fro... Class II
Dec 10, 2020 TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an i... "MLC tickle error" may result in the delivered dose to effectively rotate fro... Class II
Sep 26, 2018 CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indic... A robotics supplier notified Accuray of two manufacturing variations in the f... Class II
Aug 31, 2018 Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is ... the Ball Cube II phantom calibration film was not manufactured within necessa... Class II
Apr 10, 2018 CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic R... There is an unintended drop of a secondary collimator housing that can occur ... Class II
Apr 10, 2018 CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery Syste... There is an unintended drop of a secondary collimator housing that can occur ... Class II
Nov 17, 2017 Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy ... Uncontrolled couch Z-axis movement (descent) Class II
Nov 17, 2017 TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy tre... Uncontrolled couch Z-axis movement (descent) Class II
Nov 17, 2017 TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy trea... Uncontrolled couch Z-axis movement (descent) Class II
Nov 17, 2017 TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy tr... Uncontrolled couch Z-axis movement (descent) Class II
Dec 6, 2016 CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: T... Accuray has become aware of a potential safety issue involving the possibilit... Class II
Nov 22, 2016 CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... Accuray has become aware of a potential safety issue involving unexpected tre... Class II
Jan 22, 2016 CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover pack... The gun box mounting bracket may fail to support the weight of the gun box wh... Class II
Oct 31, 2014 CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl... Software upgrade to correct potential safety issue related to CyberKnife Syst... Class II
Jan 13, 2014 Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyval... Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one compla... Class II
Mar 27, 2013 RoboCouch Patient Positioning System Product Usage: is intended for use... A5 gearboxes responsible for pitch (head up and head down) and roll (patient ... Class II
Mar 19, 2013 Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Med... A defect on the master-side connector block of the pneumatic tool changer cou... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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