Siemens MEVATRON KD-2 Linear Accelerators Recalled for Defective Weld Seams
Siemens is recalling 35 MEVATRON KD-2 linear accelerators due to defective weld seams that could break and cause the overhead suspension to fall, posing a risk of severe injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that could cause a component to fall and result in severe injury, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the MEVATRON KD-2 linear accelerator system. These medical devices are used to deliver x-ray radiation for the therapeutic treatment of cancer. The affected units were distributed nationwide.
The recall is due to a defective weld seam located at the overhead suspensions. This defect creates a possibility for the weld seam to break, which could cause the overhead suspension to fall down. If this occurs, it can lead to severe injury to a patient or any other person in the vicinity.
Siemens has identified the specific serial numbers for the 35 affected systems. Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this defect and ensure the safety of their equipment.
The recalled product
- Product
- MEVATRON KD-2, accelerator, Linear, Medical 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
- 35
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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