Reported May 22, 2013 · Terminated
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX.…
Varian Medical Systems, Inc. Oncology Systems
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. Oncology Systems · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System
- Model Numbers
H14H27H29HCX
- Product UsageThe Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated
- Lot codes and dates
- CODES
4,035 of 4,035 codes
H140001H140064H140137H140721H140796H140862H260947H270267H270428H270539H270708H270828H271017H140002H140065H140139H140723H140797H140863H260949H270271H270430H270540H270709H270829H271018H140003H140066H140141H140724H140798H140865H260950H270273H270431H270542H270710H270833H271019H140004H140067H140143H140725H140799H140866H260951H270277H270435H270544H270711H270836H271020H140005H140068H140144H140726H140800H140868H260952H270280
- CODES
- Amount recalled
- 3943 units
Where it was sold
Why it was recalled
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
This product could cause temporary or reversible health problems — stop using it.
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