Buc, N/A, France
GE Medical Systems, SCS recalls
5 recalls recorded since 2018, most recently on 8 May 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- Reason
- GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Mo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2553-2026
- GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Ongoing Class II Medical devices
- Recall started
- 5 September 2025
- Reason
- Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0068-2026
- AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Ongoing Class II Medical devices
- Recall started
- 18 March 2024
- Reason
- GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1781-2024, Z-1779-2024, Z-1783-2024, Z-1777-2024, Z-1780-2024, Z-1778-2024, Z-1782-2024
- GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
- GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
- GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- GE Healthcare Innova IGS 5, computed tomography x-ray system
- GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
- GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
- GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Ongoing Class II Medical devices
- Recall started
- 26 December 2023
- Reason
- X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
- Distribution
- Us Nationwide-Worldwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-0862-2024
Terminated Class II Medical devices
- Recall started
- 29 March 2018
- Terminated
- 15 June 2021
- Reason
- The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
- Distribution
- US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tuni
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2387-2018, Z-2386-2018, Z-2388-2018
- Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
- Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
- Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.