Varian Linear Accelerators Recalled Due to X-Jaw Carrier Alloy Defect
Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (under-dosing) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 221 units of Varian brand Clinac, Trilogy, Novalis Tx, and Unique linear accelerators (Models H14, H18, H29) distributed worldwide. The recall is due to a manufacturing defect where some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy.
This defect can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw may move freely in the closed direction without the position readout interlock circuitry detecting the deviation. This failure may lead to patients receiving an under-dose of radiation to the intended target volume during treatment.
The affected units are identified by specific serial numbers listed in the official recall documentation. Healthcare facilities using these devices should contact Varian Medical Systems for further instructions on inspection and remediation.
The recalled product
- 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 indic
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 221
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- LIST OF SERIAL NUMBERS: H140863
- H294608
- H294669
- H294732
- H140865
- H294610
- H294670
- H294733
- H140866
- H294611
- H294671
- H294734
- H140867
- H294612
- H294672
- H294735
- H140868
- H294613
- H294673
- H294736
Distribution
Distribution scope not specified by the agency.
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