Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 310 units of various LINAC Accelerator models, including ARTISTE, ONCOR, PRIMUS, and MEVATRON series. These devices are used to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers units distributed worldwide, including the United States, Canada, and Mexico.

The recall is being conducted because reports indicate that the electric board inside the gantry may show signs of overheating. This overheating has resulted in thermal damage and smoke emission. The issue is being addressed by a hardware update that replaces the old PCB Assembly, Head Driver-G41, with a new PCB that includes overcurrent protection.

Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA, Inc. for instructions on the necessary hardware update. The specific model numbers and serial numbers affected are listed in the official recall documentation.

The recalled product

Product

LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — Radiation Therapy Equipment

Hazard

• fire
• thermal-damage
• smoke-emission

Affected units

310

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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