Siemens ARTISTE Linear Accelerator Recall for Image Quality Degradation
Siemens is recalling 8 ARTISTE linear accelerators due to potential image quality degradation that may affect patient position verification during cancer treatment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a 'potential' safety issue regarding image quality without reporting any specific injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 8 units of the ARTISTE linear accelerator system equipped with syngo RT Therapist version 4.3. The recall addresses a potential safety issue involving image quality degradation in 2D images acquired as single-exposure MV or In-Line kView images. These images are used to verify patient position during the therapeutic treatment of cancer.
The affected units are identified by Part No. 08162815. The recall covers units distributed worldwide. The source text does not specify specific dates of distribution or the number of patients affected.
Healthcare facilities using these systems should refer to the Customer Safety Advisory Notice for specific instructions on how to address the image quality degradation issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 8
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 (2)
- All units of the version 4.3
- Part No. 08162815
Distribution
Distribution scope not specified by the agency.
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