Siemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk
Siemens Medical Solutions is recalling 26 linear accelerator systems and associated software because a defect could cause automatic movement, posing a collision risk to patients.
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 risk-of-harm product (collision risk) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 26 units of ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, and Syngo RT Therapist systems. These devices are used to deliver radiation for the therapeutic treatment of cancer. The recall covers systems distributed worldwide and nationwide in the United States.
The recall is being conducted because a software defect could result in automatic movement of the equipment, creating a collision safety risk for patients. A software fix has been released to prevent this automatic movement.
Healthcare facilities using these specific systems should contact Siemens Medical Solutions to obtain the software fix. The affected units are identified by specific serial numbers and model codes listed in the official recall documentation.
The recalled product
- Product
- ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 26
Distribution
Distributed nationwide across the United States.
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