Siemens PRIMUS HI and Mevatron M2 Linear Accelerators Recalled for Weld Defect
Siemens is recalling 35 PRIMUS HI and Mevatron M2 linear accelerators due to a defective weld seam that could cause overhead suspensions to fall and injure people.
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 poses a risk of severe injury to patients or others, meeting the criteria for a Severe rating (Score 4) due to significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the PRIMUS HI and Mevatron M2/Primus Mid-Energy linear accelerators. 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 at the overhead suspensions. This defect creates a risk that the weld seam could break, causing the overhead suspension to fall down. Such an event could lead to severe injury to a patient or any other person in the vicinity.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the inspection and repair of the affected devices. Consumers and patients should not use these specific units until the defect has been addressed by the manufacturer.
The recalled product
- Product
- PRIMUS HI and Mevatron M2/Primus Mid-Energy, 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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