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Use caution Medical device recall · FDA · Published April 10, 2018

Accuray CyberKnife M6: Unintended Collimator Housing Drop During Xchange Workflows

Accuray recalls CyberKnife M6 treatment systems with specific part numbers and serials due to risk of unintended collimator housing drop during housing exchange workflows.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1696-2019Medical deviceAccuray ›
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Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
✎ GovInfoNow plain-language explainer

Accuray is recalling CyberKnife M6 radiation treatment systems with specific part numbers and serial numbers. The recall is due to a potential risk of a collimator housing dropping during housing exchange procedures, which could lead to treatment errors. Read more at govinfonow.com/recall/71485-accuray-cyberknife-m6-unintended-collimator-housing-drop-during-xchange-workflows.

Source Summary by GovInfoNow · govinfonow.com/recall/71485-accuray-cyberknife-m6-unintended-collimator-housing-drop-during-xchange-workflows · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1696-2019

Cite this page

“Accuray CyberKnife M6: Unintended Collimator Housing Drop During Xchange Workflows.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71485-accuray-cyberknife-m6-unintended-collimator-housing-drop-during-xchange-workflows. Based on FDA recall #Z-1696-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1696-2019%22&limit=1).

The FDA announced on April 10, 2018, that Accuray Incorporated is recalling CyberKnife M6 treatment delivery systems due to an unintended drop of a secondary collimator housing. The agency issued recall number Z-1696-2019 for the voluntary Class II device recall.

How to tell if you have it

  • Brand: Accuray
  • Product: CyberKnife M6 Treatment Delivery System (Part Number 0660000)
  • Product: CyberKnife M6 FI Treatment Delivery System (Part Number 053101-010)
  • Product: CyberKnife M6 FM Treatment Delivery System (Part Number 053201-010)
  • Product: CyberKnife M6 FIM Treatment Delivery System (Part Number 053301-010)
  • Product: CyberKnife M6 FI+ Treatment Delivery System (Part Number 053401-010)
  • Product: CyberKnife Matrix Tier 2 TDS (Part Number 053501-010)
  • Units affected: 68

The hazard

The recall addresses an unintended drop of a secondary collimator housing that can occur during housing Xchange workflows. Specifically, an interlock may interrupt an automated housing Xchange operation, causing the collimator housing to partially attach.

Context

GovInfoNow's records show Accuray Incorporated has 9 other recalls on record since November 17, 2017. Other recent recalls of similar products include Accuray Cyberknife System Recall: Collimator May Fall During Treatment (June 16, 2026) and Accuray CyberKnife System Recall: Snap Rings May Detach Causing Uncontrolled Rotation (December 23, 2024).

How to tell if you have this one

Check the part numbers listed in the recall notice: 0660000, 053101-010, 053201-010, 053301-010, 053401-010, or 053501-010. Also, verify the serial numbers provided for each part number.

  • Brand
    Accuray
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
Recall numberProduct, codes & lotsQuantity
Z-1696-2019CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS; a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C0444, C0445, C0446, C0447, C0448, C0449, C0450, C0453, C0454, C0456, C0457, C0458, C0460, C0464, C0465, C0466, C0472, C0475 b) 053101-010: CyberKnife M6 FI Treatment Delivery System Serial Numbers: C0334, C0381 c) 053201-010: CyberKnife M6 FM Treatment Delivery System Serial Numbers: C0363 d) 053301-010: CyberKnife M6 FIM Treatment Delivery System Serial Numbers: C0337, C0343, C0349, C0352, C0358, C0370, C0371, C0378, C0384, C0387, C0389, C0390, C0391, C0393, C0409, C0424, C0426, C0427, C0428, C0433, C0439 e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System Serial Numbers: C0330, C0332, C0342, C0344, C0345, C0348, C0359, C0360, C0364, C0367, C0372, C0394, C0398, C0400, C0402, C0404, C0415, C0419 f) 053501-010: CyberKnife Matrix Tier F TDS Serial Numbers: C039668 units
Z-1697-2019CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System; a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan Serial Numbers: C0281, C0307 b) 033000-010: CyberKnife VSI Robotic Radiosurgery System Serial Numbers: C0042, C0064, C0071, C0074, C0079, C0091, C0098, C0102, C0137, C0161, C0180, C0182, C0187, C0200, C0203, C0210, C0216, C0230, C0238, C0246, C0247, C0249, C0252, C0255, C0257, C0264, C0269, C0270, C0273, C0274, C0276, C0277, C0284, C0293, C0294, C0304, C0305, C0322, C0323, C0325, C032643 units
Based on the official FDA remedy

What to do — step by step

  1. Check Your Equipment

    Review your CyberKnife M6 system's part numbers and serial numbers against the list provided in the recall notice.

How this recall unfolded

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Apr 10, 201812. FDA classified it Class II: May 31, 201923. Published in FDA’s Enforcement Report: Jun 12, 201934. FDA terminated the recall: Apr 1, 2021420182021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What serial numbers are affected?

Serial numbers listed for each part number, such as C0434, C0436, C0437, and others, are affected.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1696-2019 (April 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1696-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA