Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect that can lead to significant patient harm (under- or over-dosing) during cancer treatment, fitting the criteria for a Severe recall due to the potential for serious injury.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Eclipse Treatment Planning System (Model H48, versions 8.9 and 10.0) due to a software anomaly. The issue occurs when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. In these instances, an outdated assigned Hounsfield Unit (HU) value may be used for dose calculation.
The use of these incorrect values can lead to under-dosing or over-dosing of patients during radiotherapy treatments. The recall affects 6,087 units distributed worldwide, including nationwide in the United States and internationally.
Healthcare facilities using the affected systems should contact Varian Medical Systems for instructions on how to resolve the synchronization issue and ensure accurate dose calculations.
The recalled product
- Product
- Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to…
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 6,087
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 (20)
- CP-08922: LIST OF SERIAL NUMBERS: H480001
- H480130
- H480301
- H480446
- H480623
- H480795
- H480976
- H481088
- H481222
- H481382
- H481544
- H481777
- H481931
- H480002
- H480131
- H480302
- H480448
- H480624
- H480798
- H480981
Distribution
Distributed nationwide across the United States.
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