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Centricity Universal Viewer (GE Healthcare) – Image Mixing (2023)

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.

High

FDASep 14, 2023Nationwide• GE Healthcare

EVIS EXERA III Video System (Olympus) – Power Supply Issue (2023)

Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

Moderate

FDASep 14, 2023Nationwide• Olympus Corporation of the Americas

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Centricity Universal Viewer (GE Healthcare) – Image Mixing (2023)

EVIS EXERA III Video System (Olympus) – Power Supply Issue (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

Aptima CMV Quant Assay (Hologic) – Sample Error (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

Stryker Portal Entry Kit (Stryker) – Expired Product (2023)

Astral Ventilators (Unknown) – Battery Alarm Fault (2023)

Breg Walker (Breg) – Misaligned Wheels (2023)

Monoject Tuberculin Syringe (Cardinal Health) – Tip Compatibility (2023)

Maquet Acrobat-i Stabilizer (Maquet) – Housing Mount Failure (2023)

RayCare (RaySearch) – Document Visibility Issue (2023)

BACTEC Culture Vials (Becton Dickinson) – Barcode Duplication (2023)

Cios Alpha C-arm (Siemens) – Software Update (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

DxI 9000 Analyzer (Beckman Coulter) – Barcode Presentation (2023)

VITROS Lipase Slides (Ortho-Clinical) – Result Bias (2023)

Cios Flow C-arm (Siemens) – Software Update (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Burn Pack (ROi CPS) – Dermatome Blade Issue (2023)

Spetzler-Malis Forceps (Stryker) – Expiration Labeling (2023)