Siemens ARTISTE syngo RT Therapist software recall for beam delivery error
Siemens is recalling 5 ARTISTE digital linear accelerators due to a software defect that may cause repeated delivery of radiation beams.
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 defect that poses a risk of harm (unintended radiation exposure) but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 5 units of the SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3 software. The affected devices are digital linear accelerators equipped with the MOSAIQ OIS system. The recall involves the "In-session resumption" feature of the software.
The recall was initiated because the software may send previously completed beams or segments for delivery again to the control console. This defect results in the repetition of already delivered Monitor Units for the same beam or segment, potentially leading to unintended radiation exposure.
All 5 affected devices are located outside of the United States in Germany. No specific instructions for consumers are provided in the source text, as the devices are located internationally.
The recalled product
- Product
- SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 5
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 (1)
- All codes/units of ARTISTE model.
Distribution
Distribution scope not specified by the agency.
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