Siemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory
Siemens Medical Solutions USA is recalling 120 digital linear accelerators nationwide to prevent patient or user injury from disabling the Automatic Motion Protection function.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential collision injuries.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 120 units of Siemens Digital Linear Accelerators nationwide. The affected models include the ARTISTE MV System, MEVATRON M2/Primus Mid-Energy, PRIMUS, PRIMUS HI, ONCOR Impression, ONCOR Impression Plus, ONCOR Avant Garde, and ONCOR Expression. The recall applies to units running specific Control Console software versions: 13.0.302 and higher, 9.2.400 and higher, or 11.0.400 and higher.
The recall was issued to advise users not to disable or bypass the Automatic Motion Protection (AMP) function. The source text states that disabling or bypassing this function for reasons of comfort is not advisable and may lead to patient or user injury due to collision with the LINAC equipment. The AMP function is implemented at the control of the Digital Linear Accelerator.
Healthcare facilities and users should ensure the AMP function remains active and not disabled or bypassed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software versio
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SIEMENS Digital Linear Accelerators of type ARTISTE"
Distribution
Distributed nationwide across the United States.
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