Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue
Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.
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 involves a medical device used for cancer treatment where a software defect could impact treatment delivery, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the ARTISTE MV System, a linear accelerator (LINAC) used to deliver x-ray radiation for the therapeutic treatment of cancer. The recall involves units equipped with SysVC10A software. The affected units have model number 08139789 and serial numbers 5419, 5784, and 5830.
The recall is due to a software issue that may result in an existing dark current phenomenon. This issue may occur when the system is used in combination with IMRT or mARC treatments that utilize unflat beams.
The affected units were distributed in the United States to the states of Utah, Wisconsin, and New York. The FDA has classified this recall as Class II. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue.
The recalled product
- Product
- ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3
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 (4)
- Model number: 08139789
- serial numbers: 5419
- 5784
- 5830
Distribution
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