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GE Medical Systems, SCS

GE Medical Systems, SCS Recalls

All product recalls associated with GE Medical Systems, SCS.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 681–700 of 3680 recalls

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

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

Low

FDADec 26, 2023Nationwide• GE Medical Systems, SCS

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Low

FDADec 22, 2023Nationwide• Howmedica Osteonics Corp.

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Low

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Page 35 of 184Next

FDA

Dec 22, 2023

Nationwide

• Howmedica Osteonics Corp.

Spectral CT on Rails (Philips) – Image Labeling Error (2023)

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

High

FDADec 13, 2023Nationwide• PHILIPS MEDICAL SYSTEMS

Spectral CT 7500 (Philips) – Image Labeling Error (2023)

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

High

FDADec 13, 2023Nationwide• PHILIPS MEDICAL SYSTEMS

Dual Articulating Headrest (Steris) – Locking Position Risk (2023)

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

High

FDADec 12, 2023Nationwide• Steris Corporation

Azurion System (Philips) – Imaging Functionality Loss (2023)

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

Moderate

FDADec 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Dual Articulating Headrest (Steris) – Locking Position Risk (2023)

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

High

FDADec 12, 2023Nationwide• Steris Corporation

Azurion FlexArm System (Philips) – Connectivity Loss (2023)

Loss of connectivity between the FlexArm and the Table due to a software issue.

High

FDADec 8, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands