# FDA recall Z-1342-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-05-20.

## Product

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

## Reason for recall

During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

## Distribution

Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-1342-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-20
- **Report date:** 2022-07-13

- **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-1342-2022

## Citation

> AI Analytics. FDA recall Z-1342-2022. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-1342-2022. Source: US FDA. Licensed CC0.

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