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Showing 10221–10240 of 11714 results

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Canon Medical System, USA, INC.: Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, ...

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Daytrana 10mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Arrow International Inc: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: DigitalDiagnost 4 High Performance. radiography and fluo...

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: ProxiDiagnost N90. radiography and fluoroscopy system

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: DigitalDiagnost 4 Flex / Value. radiography and fluorosc...

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Arrow International Inc: Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Pr...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: DigitalDiagnost C90 High Performance. radiography and fl...

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Arrow International Inc: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacin...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac...

Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

FDAMay 14, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - multi-component system for i...

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - multi-component system for in...

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer- multi-component system for in...

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Stryker Medical Division of Stryker Corporation: Proform- support surface is used to assist in the prevent...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Prime Fifth Wheel Stretcher-stretcher may be used for min...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: S3 MedSurg Bed - intended to support and transport patien...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Transport Stretcher 747 - a non-powered, wheeled device d...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: InTouch 2131-intended to support a human patient in an a...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Surgistool-intended to support a healthcare professional ...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

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