Reported Jun 12, 2019 · Terminated
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010:…
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?
- CyberKnife VSI
- Part Numbersa) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery
- System for Japan b) 033000-010CyberKnife VSI Robotic Radiosurgery System
- Lot codes and dates
- a) 032500-010CyberKnife VSI 9.6.x Robotic Radiosurgery
- System for Japan Serial NumbersC0281
- C0307 b) 033000-010CyberKnife VSI Robotic
- Radiosurgery System Serial Numbers
C0042C0064C0071C0074C0079C0091C0098C0102C0137C0161C0180C0182C0187C0200C0203C0210C0216C0230C0238C0246C0247C0249C0252C0255C0257C0264C0269C0270C0273C0274C0276C0277C0284C0293C0294C0304C0305C0322C0323C0325C0326
- Amount recalled
- 43 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Accuray Incorporated recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.