The Recall Desk
SevereFDA (Devices)·Z-1434-2017·Announced 2017-03-15

Siemens Medical Linear Accelerators Recalled for Defective Weld Seams

Siemens is recalling 35 MEVATRON M 6730/6740 linear accelerators because defective weld seams on overhead suspensions could break and fall, posing a risk of severe injury.

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 risks, warranting a score of 4 (Severe).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 35 units of the MEVATRON M 6730/6740 (MEX) linear accelerator systems. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer. The recall is due to a defective weld seam located at the overhead suspensions.

The defect creates a risk that the weld seam may break, causing the overhead suspension to fall. If this occurs, it could result in severe injury to a patient or any other person in the vicinity. The affected units were distributed nationwide.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. Consumers and patients should not use the affected equipment until the issue is resolved by the manufacturer.

The recalled product

Product
MEVATRON M 6730/6740 (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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