# FDA recall Z-1339-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-04-09.

## Product

Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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 AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

## Reason for recall

In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of  AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN,   MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT,  VA , WA WI and WV. and Foreign countries.

## Key facts

- **Recall number:** Z-1339-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-09
- **Report date:** 2019-05-22
- **Termination date:** 2020-04-23

- **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-1339-2019

## Citation

> AI Analytics. FDA recall Z-1339-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1339-2019. Source: US FDA. Licensed CC0.

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