Reported Sep 24, 2014 · Terminated
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac…
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?
- C-Series
- High Energy Linear Accelerator - ModelsNovalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated
- Lot codes and dates
Model numbers HCXH14H27H29
- Serial numbersUpdate 11-4-14-16 new installations and serial numbers added.
3,411 of 3,411 codes
H140001H140152H140724H140791H140857H140924H140985H271272H271729H272009H272180H272353H272819H140011H140201H140725H140792H140858H140925H140986H271276H271755H272014H272181H272354H272820H140018H140202H140727H140793H140859H140926H140987H271293H271759H272015H272187H272359H272822H140025H140203H140728H140795H140860H140927H140988H271308H271762H272016H272188H272362H272824H140026H140204H140729H140796H140861H140928H140989H271330
H294985H295779H295949H141042H295715H295925H295958H141026H295716H295859H295966HCX5762H295747H295877H295974HCX5771H294558H296014H294559H296016H295712H296017H295991H296031
- Amount recalled
- 3416
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
Why it was recalled
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
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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