CENTRICITY UNIVERSAL VIEWER 6.0Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

8 FDA recall records name this device's identifier, 7 still open.

8 other recalls cover devices cleared under the same FDA submission (K150420); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 30, 2026Open, Classified

   There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

   Z-1570-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Feb 19, 2025Open, Classified

   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.

   Z-1483-2025 · Root cause: Software design · Recall details · FDA record ↗

3. Feb 19, 2025Open, Classified

   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.

   Z-1487-2025 · Root cause: Software design · Recall details · FDA record ↗

4. Sep 14, 2023Open, Classified

   GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

   Z-0140-2024 · Root cause: Software design · Recall details · FDA record ↗

5. Mar 28, 2023Open, Classified

   GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

   Z-1501-2023 · Root cause: Other · Recall details · FDA record ↗

6. Jul 15, 2022Open, Classified

   Inaccurate Distance and Area measurements with use of Global Stack viewport.

   Z-1566-2022 · Root cause: Process design · Recall details · FDA record ↗

7. Aug 6, 2021Open, Classified

   Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

   Z-2503-2021 · Root cause: Software design · Recall details · FDA record ↗

8. May 16, 2019Terminated

   There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

   Z-1910-2019 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150420. One submission often covers many models, so check the product and lot details in each record.

• Z-0722-2023 · Oct 28, 2022 · Open, Classified
  Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
• Z-0819-2020 · Dec 16, 2019 · Terminated
  Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
• Z-1886-2019 · May 17, 2019 · Terminated
  Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images
• Z-0793-2019 · Dec 20, 2018 · Terminated
  GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from ot
• Z-0375-2019 · Oct 11, 2018 · Terminated
  Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
• Z-0195-2019 · Aug 30, 2018 · Terminated
  Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
• Z-2102-2018 · Jan 25, 2018 · Terminated
  Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various im
• Z-0226-2016 · Sep 28, 2015 · Terminated
  The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, commun