# FDA recall Z-1401-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-02-14.

## Product

ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

## Reason for recall

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

## Distribution

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

## Key facts

- **Recall number:** Z-1401-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-14
- **Report date:** 2018-04-25
- **Termination date:** 2019-05-16

- **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-1401-2018

## Citation

> AI Analytics. FDA recall Z-1401-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1401-2018. Source: US FDA. Licensed CC0.

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