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Siemens ARTIS One Angiographic X-Ray System - safety alert

Official notice

5 Feb 2025

MediumFDA

An official FDA notice concerns ARTIS One Angiographic X-Ray System. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-02-05. Models: 10848600. Recall numbers: Z-0922-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,140

Recall number

Z-0922-2025

Official notice

2025-02-05

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

10848600

Event Ids

96088

Model Numbers

10848600

Recall Numbers

Z-0922-2025

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Affected products

Product 1

ARTIS One Angiographic X-Ray System

Units affected

1,140

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens. Contact: SIEMENS MEDICAL SOLUTIONS USA, INC.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0922-2025

Event id

96088

Units affected

1,140

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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