Siemens MEVATRON M2 Linear Accelerator Recalled for Collision Risk
Siemens is recalling 18 MEVATRON M2 linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a risk-of-harm product (collision during treatment) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 18 units of the MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035. The device is intended to deliver x-ray radiation for the therapeutic treatment of cancer.
The recall is being conducted to update the Control Console software. This update is designed to reduce the risk of collision when delivering automatically sequenced treatments that involve automatic movements of the gantry and/or the treatment table.
The affected units were distributed worldwide, including nationwide in the United States across 24 states and Puerto Rico, as well as to Nassau. Specific serial numbers for the 18 affected units are listed in the official recall record. Users of these devices should contact Siemens Medical Solutions USA, Inc. for instructions regarding the software update.
The recalled product
- Product
- MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 18
Distribution
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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