Reported Dec 11, 2013 · Terminated
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear…
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-SeriesClinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US
- Product UsageThe Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
- Lot codes and dates
Model numbers Hl4HISH27
- H29Serial
- numbersHCXSOSS
3,568 of 3,568 codes
H140001H140136H140700H140759Hl40817H140875Hl40937H140995Hl82047H271330H271664H271935H272132H140011Hl40137H140701H140760Hl40818H140876Hl40938H140996Hl82048H271334H271666H271938H272134H140018H140138Hl40702H140761Hl40819Hl40877H140939H140997Hl82049H271344H271669H271942H272136Hl40025H140139Hl40703Hl40762Hl40820H140878H140940Hl40998Hl82050H271362H271678H271951H272137Hl40026H140140Hl40704Hl40763H140821H140879H140941H140999
240 of 240 codes
H295120H295185H295252H295324H295402H295469H295539H295616H295699HCXS088H295121H295186H295253H295325H295403H295470H295540H295618H295702HCX5104H295122H295187H295254H295326H295404H295471H295541H295620H295703HCXS113H295123H295188H295255H295330H295405H295472H295542H295621H295704HCXS137H295124H295192H295256H295331H295406H295474H295543H295622H295706HCXS164H295125H295193H295262H295332H295407H295475H295545H295623H295707HCXS189
- Amount recalled
- 3,809 devices
Where it was sold
Why it was recalled
This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
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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