# FDA recall Z-1496-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-03-30.

## Product

Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Model Numbers:  System	                Material #  AXIOM Artis FC	05904433;  AXIOM Artis FA	05904441;  AXIOM Artis MP	05904466;  AXIOM Artis BC	05904649;  AXIOM Artis BA	05904656;  AXIOM Artis dBC Mag. Nav.	05917054;  AXIOM Artis TA	07007755;  AXIOM Artis dTA	07008605;  AXIOM Artis dFC	07412807;  AXIOM Artis dTC	07413078;  AXIOM Artis dBA	07555357;  AXIOM Artis dMP	07555365;  AXIOM Artis dFA	07555373;  AXIOM Artis dFC Mag. Nav.	07727717;  AXIOM Artis TC	07728350;  AXIOM Artis dBC	07728392;  Artis zee floor	        10094135;  Artis zee ceiling	10094137;  Artis zee MP	        10094139;  Artis zee biplane	10094141;  Artis zee floor MN	10094142;  Artis zee biplane MN 10094143;  Artis Q floor	        10848280;  Artis Q ceiling	        10848281;  Artis Q biplane  	10848282;  Artis Q.zen floor	1084

## Reason for recall

Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1496-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-30
- **Report date:** 2021-05-05
- **Termination date:** 2022-07-12

- **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-1496-2021

## Citation

> AI Analytics. FDA recall Z-1496-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1496-2021. Source: US FDA. Licensed CC0.

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