# FDA recall Z-2404-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-06-30.

## Product

Artis Models with SW version VD12 listed below:  Artis zee floor	10094135  Artis zee ceiling	10094137  Artis zee MP	10094139  Artis Q floor	10848280  Artis Q ceiling	10848281	  Artis Q biplane	     10848282  Artis Q.zen floor	     10848353  Artis Q.zen ceiling     10848354  Artis Q.zen biplane   10848355    Angiography systems developed for single and biplane diagnostic imaging

## Reason for recall

Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart,  and result in delay of clinical treatment

## Distribution

US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA,  MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.

## Key facts

- **Recall number:** Z-2404-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-30
- **Report date:** 2021-09-08
- **Termination date:** 2023-02-10

- **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-2404-2021

## Citation

> AI Analytics. FDA recall Z-2404-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2404-2021. Source: US FDA. Licensed CC0.

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