What should I do if I have a Senographe Pristina system?

Stop using the device immediately and contact GE Medical Systems or your healthcare provider for further instructions.

How can I identify if my mammography system is affected?

Check the model numbers against the affected GTINs listed in the recall notice. If in doubt, consult with your healthcare provider.

Will I get reimbursed for a recalled device?

Typically, manufacturers will provide instructions for refunds or replacements. Contact GE Medical Systems for specific details.

What are the risks of using a device with missing warning labels?

Using such a device may lead to improper use and increased exposure to radiation, posing health risks.

How can I find more information about this recall?

Visit the FDA recall page linked in the recall notice for detailed information and updates.

What is a Class II recall?

A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences.

How long will the recall process take?

The timeline for refunds or replacements typically ranges from 4 to 8 weeks, depending on the manufacturer’s process.

What documentation should I keep regarding the recall?

Keep records of any communications with the manufacturer and any relevant receipts or documentation related to the purchase.

What if my healthcare provider is unresponsive regarding the recall?

If your provider does not respond, contact GE Medical Systems directly for assistance.

Are there any alternatives to the Senographe Pristina systems?

Yes, consider digital mammography systems or ultrasound breast imaging as safer alternatives.

HIGHOctober 24, 2025

GE Medical Systems Recalls Mammography Systems Over Labeling Hazard

GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: GE Medical Systems
Category: Health & Personal Care
Sold At: Multiple Retailers
At-Risk Groups: GENERAL

Hazard Information

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: N/A

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About This Product

The Senographe Pristina system is used for screening and diagnostic mammography, essential for early detection of breast cancer. Healthcare providers rely on its proper function for accurate patient assessments.

Why This Is Dangerous

The missing or incorrect X-Ray Warning labels increase the risk of improper use, which can lead to dangerous exposure to radiation. This nonconformance to FDA regulations compromises patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face delays in screening services and potential health risks if the devices are used without proper labeling.

Practical Guidance

How to identify if yours is affected

Check the model number against the list of affected GTINs.
Examine the device for any warning labels present.
Contact your healthcare provider for verification.

Where to find product info

Model numbers and GTINs can typically be found on the device’s identification label or user manual.

What timeline to expect

Expect a realistic timeline of 4-8 weeks for processing refunds or replacements.

If the manufacturer is unresponsive

Contact GE Medical Systems directly for assistance.
Document all communications in case further action is needed.

How to prevent similar issues

Always verify that medical devices have all necessary safety labels before use.
Check for current recalls on devices regularly.
Ensure devices are compliant with FDA regulations.

Documentation advice

Keep copies of receipts, correspondence with the manufacturer, and any other relevant documentation regarding the recall.

Product Details

The recall involves Senographe Pristina, Pristina Serena, and Pristina Serena 3D systems. A total of 1,818 units are affected, including 1,580 in the U.S. These systems were distributed in the U.S. and other countries.

Key Facts

Recall date: October 24, 2025
Total quantity recalled: 1,818
FDA classification: Class II
Affected models include multiple GTINs

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMammography System

Product Details

Aug 22, 2025

GE Medical Systems

If a