Varian 4D Integrated Treatment Console Recall for Safety Interlock Defect
Varian Medical Systems is recalling 512 4D Integrated Treatment Consoles because user error can allow improper clearing of safety interlocks.
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 involves a medical device safety interlock defect that could allow improper clearing of safety checks, posing a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Varian Medical Systems, Inc. is recalling 512 units of the 4D Integrated Treatment Console (4DITC), versions 10 and 11. The affected devices are identified by Model number H51 and specific serial numbers listed in the recall notice. These devices were distributed worldwide, including in the United States and numerous international locations.
The recall is issued because user error can cause the 4DITC to improperly allow users to clear a safety interlock. This interlock is imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification (BCCV) system when used with the BrainLab's ExacTract console. The 4DITC is designed to monitor linear accelerator parameters and prevent the radiation therapy device from commencing irradiation if any parameter is out of conformance with the treatment plan.
Healthcare facilities and users of the affected devices should contact Varian Medical Systems for instructions on corrective actions. The recall affects 512 devices globally.
The recalled product
- Product
- 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 512
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 (1)
- Model number H51
Distribution
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