Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian Medical Systems is recalling 1,168 units of the Eclipse Treatment Planning System because the Pencil Beam Convolution 11.0 algorithm incorrectly calculates dose for dynamic plans with different energy fields.
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, and the defect involves incorrect dose calculation in a medical device used for radiotherapy, which poses a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 1,168 units of the Varian Eclipse Treatment Planning System for Radiotherapy, Model Number H48. The recall is due to a software defect in the Pencil Beam Convolution 11.0 (PBC 11.0) algorithm. When this specific algorithm is used, the calculation of dose for dynamic plans containing different energy fields is incorrect.
The affected units were distributed worldwide and nationwide in the USA. The recall number is Z-0867-2013. The source text does not specify a date for the recall or report any specific injuries or illnesses resulting from the defect.
Healthcare providers and users of the affected software should contact Varian Medical Systems for instructions on how to address the calculation error. The source text does not provide specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 1,168
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)
- H480044
- H481353
- H482733
- H484585
- H485948
- H480045
- H481354
- H482734
- H484634
- H486024
- H480105
- H481433
- H482765
- H484673
- H486032
- H480106
- H481436
- H482827
- H484677
- H486093
Distribution
Distributed nationwide across the United States.
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