Varian VariSource iX Afterloader Systems Recalled for Calculation Errors
Varian Medical Systems is recalling 55 VariSource iX afterloader systems because a software freeze can cause incorrect radiation dose calculations.
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 defect that could lead to incorrect radiation dosing, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Varian Medical Systems Inc is recalling 55 units of the VariSource iX series afterloader systems. These are computer-controlled remote electro/mechanical systems used in brachytherapy to place a cable with an irradiated iridium seed near a malignant tumor or tumor bed.
The recall is due to a software issue where an application freeze and restart via power cycling causes the system to generate an incorrect Partial Fraction. This defect affects only systems equipped with magnetic Hard Disk Drives (HDD). The products were distributed worldwide.
Healthcare facilities should contact Varian Medical Systems for instructions on how to address the software defect. No specific instructions for end-users are provided in the source text, as these are professional medical devices.
The recalled product
- Product
- The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as…
- Manufacturer
- Varian Medical Systems Inc
- Affected units
- 55
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)
- JAQ
Distribution
Distribution scope not specified by the agency.
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