# FDA recall Z-1498-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-02-02.

## Product

ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000

## Reason for recall

If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen    Live images may not match the previously stored reference images.  Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1498-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-02
- **Report date:** 2023-05-10

- **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-1498-2023

## Citation

> AI Analytics. FDA recall Z-1498-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1498-2023. Source: US FDA. Licensed CC0.

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