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Showing 4221–4240 of 22584 results

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G8 OR Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

High

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

Prismalix OR Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

High

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

NIM TriVantage EMG Tube (Medtronic) – Monitoring Issues (2023)

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

High

FDANov 7, 2023Nationwide• Medtronic Xomed, Inc.

Abiomed Axillary Introducer (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

VERIGENE Utility Tray (Luminex) – Defective Components (2023)

Potentially defective utility trays in the reagent kits.

High

FDANov 7, 2023Nationwide• Luminex Corporation

Abiomed Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Medical System (GE) – Bolt Torque Issue (2023)

GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

High

FDANov 7, 2023Nationwide• GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Very High

FDANov 7, 2023Nationwide• Abiomed, Inc.

Navik 3D v2 (APN Health) – IFU Update (2023)

IFU update

Low

FDANov 7, 2023Nationwide• APN Health LLC

CARDIOHELP-i System (Maquet) – Factory Settings (2023)

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Moderate

FDANov 6, 2023Nationwide• Maquet Medical Systems USA

0.9% Sodium Chloride (Nurse Assist) – sterility concern (2023)

Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

AC Power Adapter (Physio-Control) – battery charging issue (2023)

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

High

FDANov 6, 2023Nationwide• Physio-Control, Inc.

0.9% Sodium Chloride (Nurse Assist) – sterility concern (2023)

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

Fountain Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

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