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Centricity Universal Viewer (GE Healthcare) – Reporting Problem (2024)

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.

Low

FDAAug 29, 2024Nationwide• GE Healthcare

Hemo-7 Hemospray (Wilson-Cook) – Raw Material Nonconformance (2024)

Specific lots of product have been manufactured with nonconforming raw materials.

Moderate

FDAAug 29, 2024Nationwide• Wilson-Cook Medical Inc.

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Centricity Universal Viewer (GE Healthcare) – Reporting Problem (2024)

Hemo-7 Hemospray (Wilson-Cook) – Raw Material Nonconformance (2024)

BIOFINITY XR TORIC Lenses (CooperVision) – Misaligned Axis (2024)

Biofinity Toric Multifocal Lenses (CooperVision) – Misaligned Axis (2024)

Good Vibrations Ultrasonic Cleaner (Microcare) – Bacterial Contamination (2024)

Medline Laparoscopy Pack (MEDLINE) – Endo Pocket Concern (2024)

Medline Open Heart (MEDLINE) – Cannulae Component Risk (2024)

Medline Kit CV I II (MEDLINE) – Cannulae Component Risk (2024)

Medline Heart CABG CDS (MEDLINE) – Cannulae Component Risk (2024)

Medline Open Heart NIMC Kit (MEDLINE) – Cannulae Component Risk (2024)

Access TSH Assay (Beckman Coulter) – Erroneously Low Results (2024)

Medline Open Heart Pack (MEDLINE) – Cannulae Component Risk (2024)

Medline Heart Overhead Table Pack (MEDLINE) – Cannulae Component Risk (2024)

Convenience Kits (Safeguard) – Incorrect Expiration (2024)

HAWK Warming Grid (Safeguard) – Incorrect Expiration (2024)

HAWK Hypothermia Set (Safeguard) – Incorrect Expiration (2024)

FastPack TSH Calibrator (Qualigen) – Barcode Mismatch (2024)

Monarch Rollator Blue (Nova Ortho-Med) – Fall Hazard (2024)

Endoscopic Flushing Pump (Olympus) – Function Loss Risk (2024)

AVS Anchor-C Cervical Cage System (Stryker) – Labeling Correction (2024)