Varian High Energy Clinacs Radiation Treatment System Recall for Beam Symmetry
Varian is recalling High Energy Clinacs because photon beams may develop asymmetry, potentially causing minor patient injury or decreased disease control.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (radiation therapy) where the source text states the potential for 'minor injury' or 'decreased local disease control' without reporting specific hospitalizations or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as severe.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 3,943 units of High Energy Clinacs, High Energy Accelerator, Radiation Treatment Systems (Model Numbers: H14, H27, H29, HCX). The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across Africa, Asia, Europe, and the Americas.
The recall is due to a potential defect where photon beams may experience a gradual change in beam symmetry. Under certain conditions, this asymmetry can reach up to about 7% before an interlock occurs. At maximum asymmetry, this may result in a dose deviation of no more than about 3.5% from expected levels at any point in the beam.
This deviation may result in minor injury to the patient or slightly decreased local disease control. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and…
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 3,943
Distribution
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