Siemens ARTISTE MV System Recalled for Collimator and Weld Defects
Siemens is recalling 194 ARTISTE MV radiation therapy systems due to incorrect collimator position displays and improper weld seams.
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 high-risk medical device (radiation therapy) with defects that could lead to improper treatment or structural failure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 194 ARTISTE MV medical charged-particle radiation therapy systems. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers systems distributed in the United States.
The recall was initiated because Siemens identified incorrect values for the rotational collimator position displayed on the systems. This issue is attributed to mechanical problems with the sensor slide. Additionally, the company identified improper weld seams at the overhead suspension of the affected units.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 194
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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