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Showing 6261–6280 of 8389 results

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CareFusion Genesis Half-Length Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

CareFusion Genesis Mini Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

CareFusion Genesis Full-Length Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

High

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

CareFusion Genesis Quarter-Length Container (CareFusion) – Sterilization Test Failure (2022)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

FDASep 26, 2022Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

GaGa Pro Laser Light Show (GaGa Pro) – FDA Standard Violation (2022)

GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.

FDASep 23, 2022Nationwide• GAGA PRO LIGHTING EQUIPMENT CO.

Hamilton-C6 (Hamilton Medical) – Screen Backlight Problem (2022)

Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.

FDASep 22, 2022Nationwide• Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland

AutoPulse Li-ion Battery (ZOLL) – Battery Failure Risk (2022)

Due to increase in Li-Ion Battery failures

FDASep 22, 2022AL, AK, AZ +44 more• ZOLL Circulation, Inc.

WEB Detachment Controller (MicroVention) – Implant Device Risk (2022)

Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels

FDASep 21, 2022Nationwide• MICROVENTION INC.

GORE CARDIOFORM ASD Occluder (Gore) – Manufacturing Test Failure (2022)

Due to manufacturing records (Release Test Results) indicating "Failed".

FDASep 21, 2022Nationwide• W L Gore & Associates, Inc.

C-Flex Polar Head Positioner (Baxter) – Adhesive Holding Failure (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

ARTIS pheno X-Ray System (Siemens) – Software Issue (2022)

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

FDASep 20, 2022Nationwide• Siemens Medical Solutions USA, Inc

MiniMed Insulin Pump (Medtronic) – Cybersecurity Vulnerability (2022)

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

FDASep 20, 2022AL, AK, AZ +49 more• Medtronic MiniMed

Allen Life Assist Beach Chair (Baxter) – Adhesive Holding Problem (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

da Vinci X (Intuitive Surgical) – Inadvertent Energy Delivery (2022)

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

FDASep 20, 2022AL, AK, AZ +24 more• Intuitive Surgical, Inc.

MiniMed Insulin Pump (Medtronic) – Cybersecurity Vulnerability (2022)

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

FDASep 20, 2022AL, AK, AZ +49 more• Medtronic MiniMed

Beach Chair Clamp (Baxter) – Adhesive Holding Failure (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Simple Clamp (Baxter) – Adhesive Holding Failure (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Vortex MP Port (Angiodynamics) – Missing Instructions (2022)

Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

FDASep 20, 2022Nationwide• Angiodynamics, Inc.

Allen Standard Spine Positioners (Baxter) – Adhesive Holding Issue (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Allen Advance Table (Baxter) – Adhesive Holding Failure (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

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