Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error
Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.
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 high-risk medical device where a software error could lead to unintended radiation exposure (risk-of-harm product), but the source text describes the scenario as 'very rare' and does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 18 ARTISTE and ONCOR Digital Linear Accelerators equipped with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X. These devices are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall is issued due to a potential safety issue involving the IMMEDIATE RESUMPTION feature. In a very rare scenario, if a Control Console interlock occurs during the delivery of flattening-filter-free (Multiple-X) beams or segments, the system may send the previously completed beam or segment for delivery again. This could result in the repetition of already delivered Monitor Units, leading to an unintended radiation dose.
The affected units were distributed worldwide, including in the United States (specifically Florida), Germany, India, Poland, Thailand, and the Republic of Korea. Affected part numbers include 08139789 (ARTISTE), 05863472 (ONCOR Avant Garde), 05857912 (ONCOR Impression Plus), and 07360717 (ONCOR Expression). Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on managing the affected equipment.
The recalled product
- Product
- ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 18
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 (8)
- ARTISTE
- Part #: 08139789
- ONCOR Avant Garde
- Part #: 05863472
- ONCOR Impression Plus
- Part #: 05857912
- ONCOR Expression
- Part #: 07360717
Distribution
Distributed in 1 state:
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