GE Healthcare: Device Recall

Recall #Z-3214-2024 · 08/05/2024

Class II: Risk

Recall Details

Recall Number: Z-3214-2024
Classification: Class II
Product Type: Device
Recalling Firm: GE Healthcare
Status: Ongoing
Date Initiated: 08/05/2024
Location: Chicago, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2138 units

Reason for Recall

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.

Product Description

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

Distribution Pattern

Worldwide distribution.

Other Recalls by GE Healthcare

Class II: Risk 02/19/2025

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

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

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

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

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.

View all recalls by GE Healthcare →

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.