The Recall Desk
SevereFDA (Devices)·Z-1433-2017·Announced 2017-03-15

Siemens Medical Recalls 35 MEVATRON M 6700 Linear Accelerators

Siemens Medical Solutions USA is recalling 35 MEVATRON M 6700 linear accelerators due to a defective weld seam that could cause the overhead suspension to fall and injure a patient or other person.

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 recall involves a structural defect in a medical device that could cause a component to fall and result in severe injury to a patient or other person, meeting the criteria for a Severe (4) rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 35 units of the MEVATRON M 6700 (MX) 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. The affected devices are distributed nationwide.

The recall is due to a defective weld seam at the overhead suspensions. This defect makes it possible for the weld seam to break, which could cause the overhead suspension to fall down. If this occurs, it can lead to a severe injury to a patient or any other person.

The source text does not specify a date for the recall, the number of reported injuries, or specific instructions for consumers beyond the identification of the hazard. Affected serial numbers are listed in the structured product information.

The recalled product

Product
MEVATRON M 6700 (MX) 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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