GE Medical Systems, SCS: Senographe Pristina X-Ray Systems Recalled for Audible Signal Failure

Agency Publication Date: February 8, 2024

Summary

GE Medical Systems is recalling 180 Senographe Pristina mammography systems equipped with Efficiency Suite 2 because the audible signal that indicates X-ray exposure has ended may intermittently fail to sound. This failure to emit a required tone violates safety requirements under 21CFR 1020.31(j) and could lead to confusion regarding the status of radiation exposure. This recall affects 60 units in the United States and 120 units worldwide.

Risk

If the audible signal fails, the operator may not be clearly notified when the X-ray exposure has finished, potentially leading to errors in equipment operation or unnecessary radiation concerns. While no injuries have been reported, the device fails to meet federal safety standards for radiation-emitting products.

What You Should Do

Identify if your facility's Senographe Pristina system is affected by checking the Global Trade Item Number (GTIN) on the device labeling or system documentation against the following affected codes: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, or 840682145879.
Confirm if your Senographe Pristina system is equipped with the Efficiency Suite 2 software package, as this specific configuration is the subject of the recall.
Contact your GE HealthCare representative or the manufacturer, GE Medical Systems, SCS, to discuss the required software update or technical correction for this intermittent signaling issue.
Report any malfunctions or signaling failures experienced during clinical use to GE Medical Systems or through the FDA's MedWatch reporting program.
For additional information or assistance, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential remedy regarding the intermittently missing audible signal.

Affected Products

Product: Senographe Pristina with Efficiency Suite 2

Model / REF:

Z-0862-2024

UPC Codes:

195278022745

195278276971

195278628916

195278661999

195278665379

840682118460

840682142052

840682145879

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93837

Status: Active

Manufacturer: GE Medical Systems, SCS

Sold By: GE Medical Systems; Authorized Medical Device Distributors

Manufactured In: France

Units Affected: 180 units (60 US; 120 OUS)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your facility's Senographe Pristina system is affected by checking the Global Trade Item Number (GTIN) on the device labeling or system documentation against the following affected codes: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, or 840682145879.

Confirm if your Senographe Pristina system is equipped with the Efficiency Suite 2 software package, as this specific configuration is the subject of the recall.

Contact your GE HealthCare representative or the manufacturer, GE Medical Systems, SCS, to discuss the required software update or technical correction for this intermittent signaling issue.

Report any malfunctions or signaling failures experienced during clinical use to GE Medical Systems or through the FDA's MedWatch reporting program.

For additional information or assistance, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).