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Centricity Universal Viewer (GE Healthcare) – measurement inaccuracy (2022)

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

Centricity Cardiology CA1000 (GE Healthcare) – measurement inaccuracy (2022)

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

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Centricity Universal Viewer (GE Healthcare) – measurement inaccuracy (2022)

Centricity Cardiology CA1000 (GE Healthcare) – measurement inaccuracy (2022)

Sodium Bicarbonate System (Isopure) – electrical short risk (2022)

Centricity PACS RA1000 (GE Healthcare) – measurement inaccuracy (2022)

Centricity Radiology RA600 (GE Healthcare) – measurement inaccuracy (2022)

Axium Detachable Coil System (Micro Therapeutics) – labeling error (2022)

X80 RADiant Therapy System (Xstrahl) – compatibility issue (2022)

BVI Wet-Field Eraser (Beaver Visitec) – incorrect product (2022)

1 Series CX Phototherapy (Daavlin) – calibration software issue (2022)

4 Series CX Phototherapy (Daavlin) – calibration software issue (2022)

GE Healthcare Backup Batteries (GE Healthcare) – early failure (2022)

Avance CS2 Backup Batteries (GE Healthcare) – early failure (2022)

Safe-t-Centesis Catheter (Bard) – needle size mismatch (2022)

EVIS EXERA II Videoscope (Olympus) – part replacement error (2022)

Ivenix Infusion System (Fresenius) – pump start-up time (2022)

SUR-FIT Natura Wafer (ConvaTec) – skin barrier issue (2022)

Surgical Suture Kit (Stradis) – sterile barrier uncertainty (2022)

INTERTAN Nail (Smith & Nephew) – left-right labeling error (2022)

Locking Cap (Baxter) – regulatory clearance issue (2022)

5 Prong Manifold Set (Baxter) – regulatory clearance issue (2022)