Reported Sep 26, 2012 · Terminated
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA…
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 brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators
- Model Number
H14H18H29
- Reference/FSCA IdentifierCP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The 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
- Lot codes and dates
- LIST OF SERIAL NUMBERS
221 of 221 codes
H140863H294608H294669H294732H140865H294610H294670H294733H140866H294611H294671H294734H140867H294612H294672H294735H140868H294613H294673H294736H140869H294614H294674H294737H140870H294615H294675H294738H140871H294616H294676H294739H140872H294617H294677H294740H140873H294618H294678H294741H140874H294619H294679H294742H140875H294620H294680H294743H140876H294621H294681H294744H140877H294622H294682H294745H140878H294623H294683H294746
- LIST OF SERIAL NUMBERS
- Amount recalled
- 221 Units
Why it was recalled
Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
This product could cause temporary or reversible health problems — stop using it.
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