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Showing 10161–10180 of 11714 results

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Medtronic Heart Valves Division: CoreValve Evolut PRO PLUS Delivery Catheter System, REF: ...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Abbott Laboratories: REF: 08P1820, Abbott Alinity c Activated Alanine Aminotr...

There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.

FDAJun 10, 2021Nationwide• Abbott Laboratories

Abbott Laboratories: REF 8L92-22, Abbott Activated Alanine aminotransferase, f...

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

FDAJun 10, 2021Nationwide• Abbott Laboratories

Abbott Laboratories: REF 8L92-42, Abbott Activated Alanine Aminotransferase, f...

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

FDAJun 10, 2021Nationwide• Abbott Laboratories

Abbott Laboratories: REF 8L92-21, Abbott Activated Alanine Aminotransferase, f...

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

FDAJun 10, 2021Nationwide• Abbott Laboratories

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Medtronic Vascular, Inc.: Medtronic Endurant IIs Stent Graft System Medtronic Endu...

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

FDAJun 7, 2021GA, MD, MA +5 more• Medtronic Vascular, Inc.

Medtronic Vascular, Inc.: Endurant II/Endurant IIs Stent Graft System: Medtronic E...

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

FDAJun 7, 2021GA, MD, MA +5 more• Medtronic Vascular, Inc.

GE Healthcare, LLC: SIGNA PET/MR, Tomographic Imager Combining Emission Compu...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Pioneer - Product Usage: is a whole body magnetic r...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imag...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR750 3.0T - Product Usage: is a whole body mag...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging Sy...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR750w 3.0T - Product Usage: is a whole body ma...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging ...

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDAJun 4, 2021Nationwide• GE Healthcare, LLC

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