# FDA recall Z-0441-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-12-09.

## Product

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.  Model Number: 8162815

## Reason for recall

Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

## Distribution

US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.

## Key facts

- **Recall number:** Z-0441-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-09
- **Report date:** 2022-01-05
- **Termination date:** 2023-05-04

- **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-0441-2022

## Citation

> AI Analytics. FDA recall Z-0441-2022. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0441-2022. Source: US FDA. Licensed CC0.

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