Reported Jun 12, 2019 · Terminated
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment…
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 0660000: CyberKnife Treatment Delivery System |
| 2 | 053101-010: CyberKnife M6 FI Treatment Delivery System |
| 3 | 053201-010: CyberKnife M6 FM Treatment Delivery System |
| 4 | 053301-010: CyberKnife M6 FIM Treatment Delivery System |
| 5 | 053401-010: CyberKnife M6 FI+ Treatment Delivery System |
| 6 | 053501-010: CyberKnife Matrix Tier 2 TDS |
- Lot codes and dates
- a) 0660000CyberKnife Treatment
- Delivery System Serial Numbers
C0434C0436C0437C0438C0440C0441C0443C0444C0445C0446C0447C0448C0449C0450C0453C0454C0456C0457C0458C0460C0464C0465C0466C0472
- C0475 b) 053101-010CyberKnife M6 FI Treatment
- Delivery System Serial NumbersC0334
- C0381 c) 053201-010CyberKnife M6 FM Treatment
- Delivery System Serial NumbersC0363
- d) 053301-010CyberKnife M6 FIM Treatment
- Delivery System Serial Numbers
C0337C0343C0349C0352C0358C0370C0371C0378C0384C0387C0389C0390C0391C0393C0409C0424C0426C0427C0428C0433
- C0439 e) 053401-010CyberKnife M6 FI+ Treatment
- Delivery System Serial Numbers
C0330C0332C0342C0344C0345C0348C0359C0360C0364C0367C0372C0394C0398C0400C0402C0404C0415
- C0419 f) 053501-010CyberKnife
- Matrix Tier F TDS Serial NumbersC0396
- Amount recalled
- 68 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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