Reported Sep 24, 2014 · Terminated
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery…
Varian Medical Systems, Inc.
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: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
- Lot codes and dates
- Model number H51
- Serial numbers
512 of 512 codes
H51B429H514517H511720H514463H511002H513925H514115H510855H515068H514544H512492H515879H515060H513064H514438H514022H512957H514553H515102H515991H515511H51B421H515106H514189H513551H513009H515033H51B568H515804H51B611H515004H513477H513133H513562H510966H515691H513894H515363H513801H51B362H518326H518191H514863H513889H514050H515619H515282H515413H51B240H515815H51B204H512299H513438H51B233H510451H512146H512507H515601H513692H51B136
- Amount recalled
- 512 affected devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
This product could cause temporary or reversible health problems — stop using it.
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