Lower risk Medical device recall · FDA · Published December 26, 2023

GE Medical Systems Senographe Pristina X-ray Machine Recall: Audible Signal Failure

GE Medical Systems recalls Senographe Pristina X-ray machines with Efficiency Suite 2 due to intermittent failure of the X-ray exposure termination audible signal, which may lead to incomplete imaging. Affected units have specific GTINs listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0862-2024Medical device GE Medical Systems ›

Lower-risk recall

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

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Contact the company

Recalling firmGE Medical Systems, SCS283 rue de la Miniere · Buc, France

✎ GovInfoNow plain-language explainer

GE Medical Systems is recalling Senographe Pristina X-ray machines with Efficiency Suite 2 because the audible signal that stops X-ray exposure may not work properly. This could cause incomplete imaging during procedures, but it does not pose a risk of injury to patients or staff. Read more at govinfonow.com/recall/56468-ge-medical-systems-senographe-pristina-x-ray-machine-recall-audible.

Source Summary by GovInfoNow · govinfonow.com/recall/56468-ge-medical-systems-senographe-pristina-x-ray-machine-recall-audible · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0862-2024

Cite this page

“GE Medical Systems Senographe Pristina X-ray Machine Recall: Audible Signal Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56468-ge-medical-systems-senographe-pristina-x-ray-machine-recall-audible. Based on FDA recall #Z-0862-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0862-2024%22&limit=1).

The FDA announced on December 26, 2023, that GE Medical Systems SCS is recalling Senographe Pristina units due to a hazard involving the intermittent failure of an X-ray exposure termination audible signal. The agency issued recall number Z-0862-2024 for the Class II device.

How to tell if you have it

Brand: GE Medical Systems
Product: Senographe Pristina with Efficiency Suite 2
GTINs: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Quantity: 180 units (60 US; 120 OUS)

The hazard

The recall addresses the intermittent failure of the X-ray exposure termination audible signal on Senographe Pristina systems equipped with Efficiency Suite 2. This malfunction violates 21CFR 1020.31(j) requirements for the emission of the signal.

Context

GovInfoNow's records show GE Medical Systems SCS has issued four other recalls since March 29, 2018. Recent brand actions include a May 8, 2026, recall of GE Healthcare AW Server 3.2 ext.6.5 for patient image mix-up risks and a September 5, 2025, alert regarding security vulnerabilities in AW Server products. Other recent recalls of similar products include the March 18, 2024, recall of GE Healthcare Allia IGS 5 Pulse X-Ray Systems for potential gantry fall risks, the October 24, 2025, recall of GE Medical Systems Senographe Pristina Mammography Machines for missing warning labels, and recalls of Philips Azurion 5 M12 systems (March 3, 2026) and Micro-X Rover Mobile X-ray Systems (March 27, 2026).

How to tell if you have this one

Check for the Senographe Pristina model with Efficiency Suite 2. Affected units have specific GTINs listed in the recall notice: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879.

Brand
GE Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product GTINs
Verify if your Senographe Pristina X-ray machine has one of the listed GTINs: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Us Nationwide-Worldwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 50 days after the firm started it.

Dec 26, 2023Firm started the recall
Feb 8, 2024FDA classified it Class II
Feb 14, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56468-ge-medical-systems-senographe-pristina-x-ray-machine-recall-audible">GE Medical Systems Senographe Pristina X-ray Machine Recall: Audible Signal Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0862-2024 (December 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0862-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.