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Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Moderate

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Proteus XR/a X-Ray System (GE Healthcare) – Missing Manual (2024)

The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

Moderate

FDAJul 12, 2024Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

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Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)

Proteus XR/a X-Ray System (GE Healthcare) – Missing Manual (2024)

Aespire 7100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Aespire 100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

NavaClick Syringe (Lineage Biomedical) – Incorrect GTIN (2024)

Aisys CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Aespire View (Datex-Ohmeda) – Gas Outlet Risk (2024)

RMU-2000 Chest Compression Device (Defibtech) – Motor Failure (2024)

2090 Programmers (Medtronic) – Cursor Motion Issue (2024)

DxC 500 AU Analyzer (Beckman Coulter) – Software Rack Limitation (2024)

VITROS XT ALB-TP Slides (Ortho-Clinical) – Dust Shedding (2024)

Guidewire (Bard Peripheral Vascular) – Misassembly Risk (2024)

Proton Therapy System (IBA) – Positioning System Issue (2024)

DxI 9000 Analyzer (Beckman Coulter) – Pneumatics Tubing Leak (2024)

TruDi NAV Suction (Integra LifeSciences) – Calibration Error (2024)

Aurora 2 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

Pyxis QFill Station (CareFusion) – Label Printing Issue (2024)

Aurora 3 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

McGRATH MAC EMS Laryngoscope (Covidien) – Battery Risk (2024)

Kiestra Urine Culture App (Becton Dickinson) – Inaccurate Counting (2024)