The Recall Desk
SevereFDA (Devices)·Z-1435-2017·Announced 2017-03-15

Siemens MEVATRON M 7400/7440 Linear Accelerators Recalled for Defective Welds

Siemens is recalling 35 MEVATRON M 7400/7440 linear accelerators because a defective weld seam could break, causing the overhead suspension to fall and potentially injure patients or others.

What this means for you

Illness, injury, or structural failure has been reported. 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 (Severe).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 35 MEVATRON M 7400/7440(MEX) linear accelerator systems. These devices are used to deliver x-ray radiation for the therapeutic treatment of cancer. The recall involves specific serial numbers listed in the agency's structured product information.

The recall was initiated because Siemens identified 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.

The affected systems were distributed nationwide. Siemens is the recalling firm. Users of these devices should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect.

The recalled product

Product
MEVATRON M 7400/7440(MEX) 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
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.

See all 6 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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