# FDA recall Z-2367-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-07-30.

## Product

Artis zee and Artis Q/ Q.zen  Interventional Fluoroscopic X-Ray System with patient tables as follows:    Systems                   Material Number  Artis zee biplane      10094141;  Artis Q floor	         10848280;  Artis Q biplane	         10848282;  Artis Q.zen floor        10848353;  Artis Q.zen biplane   10848355;  Artis zee ceiling	 10094137;  Artis Q ceiling           10848281;  Artis Q zeego           10848283  ArtisQ.zen ceiling     10848354    Product Usage:  Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. The Artis family can also support the acquisition of position triggered imagin

## Reason for recall

Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and  cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts

## Distribution

US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX,  WI

## Key facts

- **Recall number:** Z-2367-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-30
- **Report date:** 2019-09-04
- **Termination date:** 2020-04-29

- **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-2367-2019

## Citation

> AI Analytics. FDA recall Z-2367-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2367-2019. Source: US FDA. Licensed CC0.

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