Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues
Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.
What this means for you
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 (linear accelerator) with a software defect addressing safety issues, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 103 units of the ARTISTE family of linear accelerator systems. These medical devices are used to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The recall is being conducted to install a software patch that addresses several safety issues.
The affected units are distributed nationwide. The recall covers specific model numbers 08162815 and 8168754, along with a list of specific serial numbers provided in the agency's documentation. The source text does not specify the exact nature of the safety issues or report any injuries or illnesses associated with the defect.
Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA, Inc. to arrange for the installation of the required software patch.
The recalled product
- Product
- ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM 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
- 103
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 (20)
- Model # 08162815
- 8168754 Serial # 10019
- 10626
- 10651
- 10672.10678
- 10702
- 10703
- 10706
- 10712
- 10758
- 10767
- 10804
- 10625
- 10063
- 10770
- 10831
- 10008
- 10786
- 10789
- 10756
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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