Varian Segmented Cylinder Applicator Set Recalled for Potential Slippage During Treatment
Varian Medical Systems is recalling 21 Segmented Cylinder Applicator Sets used for brachytherapy because they may slip during treatment, causing radiation to be delivered to areas outside the target.
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 where a mechanical failure (slippage) could result in unintended radiation exposure. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling 21 units of the Segmented Cylinder Applicator Set, Model # GM11004150. These devices are used during pulsed dose rate (PDR) brachytherapy to treat vaginal and rectal cancer.
The recall is being conducted because the segmented cylinder applicator set may slip during treatment. This slippage can cause the delivery of radiation to areas outside the intended target. The affected devices were distributed worldwide, including in the United States, Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Healthcare providers and facilities using these devices should stop using the affected units and contact Varian Medical Systems for further instructions. The specific serial numbers for the recalled devices are H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, and H640387.
The recalled product
- Product
- Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 21
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 (9)
- Serial numbers H640383
- H640277
- H640384
- H640788
- H640D126
- H640385
- H640372
- H640303
- H640387
Distribution
Distributed nationwide across the United States.
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