Varian Eclipse Treatment Planning System Recall for Radiotherapy Prescription Errors
Varian is recalling Eclipse Treatment Planning Systems because changing dose prescriptions in certain plans may result in incorrect Monitor Units and dose distributions.
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. The hazard involves a software anomaly in a medical device used for cancer treatment that could lead to incorrect dosing, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Eclipse Treatment Planning System (Model H48) used for planning radiotherapy treatments. The recall involves 7,113 units distributed worldwide, including in the United States and numerous international markets.
The recall was initiated due to an identified anomaly where changing the dose prescription in a calculated VMAT or RapidArc plan after the initial Dose Volume Optimization may lead to Monitor Units that do not reflect the new prescription. Consequently, the dose distribution may not accurately match the intended treatment plan.
Healthcare facilities using the affected devices should contact Varian Medical Systems for further instructions on how to address the issue. The source text does not specify specific actions for patients or additional remediation steps beyond the identification of the anomaly.
The recalled product
- Product
- Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for…
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 7,113
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)
- Affected Devices: H480110
- H486186
- H48B178
- H48D026
- H48D966
- H487806
- H48B764
- H48B218
- H48C503
- H488467
- H481815
- H48D923
- H48E486
- H480267
- H486446
- H48B179
- H48D027
- H48A565
- H487807
- H48B765
Distribution
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