Varian C-Series Linear Accelerators Recalled for Beam Output Decrease
Varian Medical Systems is recalling C-Series High Energy Linear Accelerators due to a trend of unexpected decreases in beam output during 6MV photon treatment.
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 involves a high-risk medical device where a defect (decreased beam output) poses a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Varian Medical Systems, Inc. is recalling specific models of C-Series High Energy Linear Accelerators, including Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, and Clinac 23EX. The recall applies to units with versions 7, 8, 9, and 6 MV configuration with a maximum dose rate of at least 6000 MU/min. Approximately 3,416 units are affected.
The recall was initiated due to a trend in reports of an unexpected decrease in beam output in the 6MV photon treatment mode. This device is intended to provide stereotactic radiosurgery and precision radio-therapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and users should contact Varian Medical Systems for further instructions on how to address the beam output issue.
The recalled product
- Product
- C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Ac
- Manufacturer
- Varian Medical Systems, Inc.
- Hazard
- Affected units
- 3,416
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 (3)
- Model numbers HCX
- H14
- H27
Distribution
Distributed nationwide across the United States.
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