Siemens Medical Linear Accelerators Recalled for Defective Overhead Suspension Welds
Siemens is recalling 35 linear accelerator systems due to defective weld seams that could cause overhead suspensions 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 source text explicitly states that the defect can lead to a 'severe injury' to a patient or other person, which aligns with the rubric criterion for 'significant injury' reports or risk, warranting a score of 4.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the MEVATRON MD-2, MEVATRON MDX-2, and MEVATRON ME linear accelerator systems. These devices are used to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers systems with specific model numbers and serial numbers distributed nationwide.
The recall was initiated because Siemens identified a defective weld seam at the overhead suspensions. This defect creates a possibility 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 and users of these specific linear accelerator systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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
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 (2)
- Device Model Number 9401654
- 9401746
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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