# FDA recall Z-1294-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-06-10.

## Product

Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

## Reason for recall

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

## Distribution

Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam

## Key facts

- **Recall number:** Z-1294-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-10
- **Report date:** 2022-07-06

- **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-1294-2022

## Citation

> AI Analytics. FDA recall Z-1294-2022. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-1294-2022. Source: US FDA. Licensed CC0.

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