GE Healthcare

9 FDA enforcement actions

9 Total Recalls

0 Class I

9 Class II

0 Class III

Firm Details

Product Types: device
States: IL

All Recalls

Class II: Risk 02/19/2025 device

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Class II: Risk 02/19/2025 device

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Class II: Risk 02/19/2025 device

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Class II: Risk 02/19/2025 device

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Class II: Risk 02/19/2025 device

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Class II: Risk 10/03/2024 device

GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
Class II: Risk 08/29/2024 device

GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
Class II: Risk 08/05/2024 device

GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
Class II: Risk 07/23/2024 device

Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.