Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues
Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.
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 risk-of-harm product (radiation therapy device) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 103 units of the PRIMUS family of linear accelerator systems. These medical devices are used to deliver x-ray 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 involves specific model numbers 08162815 and 8168754, along with a list of specific serial numbers provided in the official notice. The agency has classified this recall as Class II.
Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA, Inc. to arrange for the installation of the necessary software patch.
The recalled product
- Product
- PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for 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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