# FDA recall Z-1204-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-03-20.

## 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 version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.400 and higher.

## Reason for recall

Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the  Auto Field Sequence (AFS) Automatic Motion Protection (AMP)  function implemented at the control of the Digital Linear Accelerator.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1204-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-20
- **Report date:** 2019-05-01
- **Termination date:** 2020-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1204-2019

## Citation

> AI Analytics. FDA recall Z-1204-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1204-2019. Source: US FDA. Licensed CC0.

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