Elekta RT Desktop Software Recall for Calibration Input Errors
Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.
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 used for radiation therapy where incorrect calibration values could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Elekta, Inc. is recalling 489 units of the RT Desktop software. This software serves as the user interface for SL/SLi Series Linear Accelerators, which are used for radiation therapy treatments of malignant neoplastic diseases.
The recall is due to a potential for users to type incorrect values or invert a value during the treatment table, gantry, and collimator calibration procedures. The affected software versions are R4.2, R5.0, R5.1, R6.0, and R6.1.
The product was distributed worldwide, including in the United States and numerous international countries. No specific instructions for consumers are provided in the source text, but the recall is managed by Elekta, Inc.
The recalled product
- Product
- RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a…
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 489
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 (5)
- R4.2
- R5.0
- R5.1
- R6.0
- R6.1
Distribution
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