Accuray Incorporated recalls
Every recall we track for Accuray Incorporated — 15 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
15 recalls since 2017. 27% rated “stop using now”.
All FDA recall records for Accuray Incorporated since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 4 | 0 | 0 | 0 | 4 |
| 2018 | 0 | 2 | 2 | 0 | 4 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 2 | 2 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 2 | 0 | 0 | 2 |
Most common reasons for Accuray Incorporated recalls
What to do if you have a recalled Accuray Incorporated product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Accuray Incorporated recalls
10 shown- Use cautionMedical device
Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Accuray recalls Cyberknife treatment systems with specific software versions due to risk of collimator falling during treatment. Affected units may require repair or replacement to prevent injury.
AccurayJun 16, 2026 - Use cautionMedical device
Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Accuray recalls Cyberknife systems with specific software versions where a collimator could fall during treatment, posing a risk of injury. Affected units include those with Xchange Robotic Collimator Changer and Linear Accelerator running software 11.X or higher.
AccurayJun 16, 2026 - Use cautionMedical device
Accuray Incorporated recalls CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM
Accuray recalls CyberKnife Treatment Delivery Systems with specific unit numbers due to snap rings that may detach, causing uncontrolled rotation and potential safety risks during radiation therapy procedures.
AccurayDec 23, 2024 - Use cautionMedical device
Accuray Incorporated recalls Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Accuray recalls specific Radixact Treatment Delivery System upper roller brackets (part 1088370) for potential service safety hazards during equipment maintenance.
AccurayAug 3, 2023 - Use cautionMedical device
Accuray Incorporated recalls CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and
Accuray recalls CyberKnife treatment systems with set screws that can loosen over time, potentially causing the treatment couch to roll. Affected units include specific product codes and serial numbers listed in the recall.
AccurayFeb 26, 2021 - UnratedMedical device
Accuray Incorporated recalls TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and
Accuray recalls TomoTherapy Treatment Delivery System with iDMS due to potential dose rotation error during radiation therapy. Affected units have specific product codes and serial numbers. Contact Accuray for remedy details.
AccurayDec 10, 2020 - Lower riskMedical device
Accuray Incorporated recalls CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided
Accuray recalls CyberKnife M6 Systems with specific serial numbers due to potential manufacturing variations that could lead to premature component failure. Affected units include 60+ models with serial numbers starting with C0330 to C0464.
AccuraySep 26, 2018 - Lower riskMedical device
Accuray Incorporated recalls Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Ashland Box Film Ball Cube II EBT3 calibration film (P/N 027863-002 rev E) sold between Aug 2017-July 2018 may cause up to 0.5mm positional error in CyberKnife systems. Affected units should be checked for model and serial number.
AshlandAug 31, 2018 - Use cautionMedical device
Accuray Incorporated recalls CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment
Accuray recalls CyberKnife M6 treatment systems with specific part numbers and serials due to risk of unintended collimator housing drop during housing exchange workflows.
AccurayApr 10, 2018 - Stop using nowMedical device
Accuray Incorporated recalls TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an
Accuray recalls TomoHDA System model 1018286 due to uncontrolled couch descent during radiation therapy. Affected units have specific serial numbers; stop using immediately to prevent injury.
AccurayNov 17, 2017
Accuray Incorporated recall questions
How many recalls has Accuray Incorporated had?
15 recalls from Accuray Incorporated are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Accuray Incorporated recall?
Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator, dated Jun 16, 2026. Every Accuray Incorporated recall is listed on this page, newest first.
Why are Accuray Incorporated products recalled?
The most common reasons on record: Uncontrolled couch Z-axis movement (descent) (4).
What should I do if I have a recalled Accuray Incorporated product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Accuray Incorporated recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.