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Varian Medical Systems, Inc. Oncology Systems recalls Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Iden
Recalled September 26, 2012 · FDA recall Z-2383-2012 · Varian Medical Systems, Inc. Oncology Systems
Hazard
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. · FDA Class II
Units
221 Units
Sold at
Worldwide Distribution.
Description
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.
Product
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-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.
Manufacturer(s)
Varian Medical Systems, Inc. Oncology Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →