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GE Vivid S70N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

Moderate

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

Custom Medical Procedure Packs (DeRoyal) – Package Seal Compromise (2023)

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Moderate

FDAMay 30, 2023Nationwide• DeRoyal Industries Inc

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GE Vivid S70N Ultrasound (GE Vingmed) – System Boot Delay (2023)

Custom Medical Procedure Packs (DeRoyal) – Package Seal Compromise (2023)

VISERA Tracheal Intubation Videoscope (Olympus) – Reprocessing Compatibility (2023)

Tracheal Intubation Fiberscope (Olympus) – Reprocessing Compatibility (2023)

Olympus Endoscope Reprocessor (Olympus) – Reprocessing Compatibility (2023)

Abiomed Introducer Set (Abiomed) – Sidearm Detachment Risk (2023)

Flexiva Pulse ID 242 TracTip single Use Fiber-intended to... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse 242 Single-Use Laser Fibers-intended to be ... (Boston Scientific Corporation) – burn hazard (2023)

Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Tropo... (QUIDEL CARDIOVASCULAR INC) – raw material issue may cause cardiac ... (2023)

Slick Set Cuffed Tube (TELEFLEX) – Connector Disconnection (2023)

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - inten... (Boston Scientific Corporation) – burn hazard (2023)

RUSCHELIT Tracheal Tube (TELEFLEX) – Connector Disconnection (2023)

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregi... (Philips Respironics, Inc.) – there are errors present in the korea... (2023)

Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse ID-intended to be used as a device that tra... (Boston Scientific Corporation) – burn hazard (2023)

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT r... (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

Slick Set Uncuffed Tube (TELEFLEX) – Connector Disconnection (2023)

Preformed AGT Oral Tube (TELEFLEX) – Connector Disconnection (2023)