CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
CyberKnife M6, Part Numbers: a) recalled by Accuray Incorporated
Accuray is recalling CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b). The recall was initiated on 10 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1696-2019
- FDA event ID
- 82664
- Recalling firm
- Accuray, Madison, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Apr 2018
- FDA classified
- 31 May 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Apr 2018 | Recall initiated by company | |
| 31 May 2019 | Classified by FDA | +416 days |
| 12 Jun 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Product as listed by the FDA
CyberKnife 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
Where it was distributed
US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
Questions about this recall
Why was it recalled?
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Which lots are affected?
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: C0396
Where was it sold?
US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82664| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CyberKnife VSI, Part Numbers: a) recalled by Accuray Incorporated | Accuray | Other | WI |
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All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
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| Device | CLASS II | CyberKnife Treatment Delivery System recalled by Accuray Incorporated | Accuray | Other | Nationwide |
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