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Showing 3981–4000 of 8389 results

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XScribe Cardiac Stress System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Azurion FlexArm System (Philips) – Connectivity Loss (2023)

Loss of connectivity between the FlexArm and the Table due to a software issue.

FDADec 8, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

XScribe Cardiac Testing System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Moderate

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Mega Soft Universal Plus Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

MINC+ Benchtop Incubator (Cook) – Temperature Control Issue (2023)

The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.

FDADec 7, 2023CA, IN, LA +2 more• Cook Medical Llc

Terragene Bionova PCD (Unknown) – Instructions for Use Discrepancy (2023)

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

FDADec 7, 2023Nationwide

ExcelsiusGPS Fluoroscopy Kit (Globus) – Calibration Error (2023)

A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

FDADec 7, 2023CA, CO, MT +2 more• Globus Medical, Inc.

Cobalt XT Defibrillator (Medtronic) – Battery Assembly Issue (2023)

During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.

FDADec 7, 2023Nationwide• Medtronic Inc.

Terragene Integron (Unknown) – Instructions for Use Discrepancy (2023)

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

FDADec 7, 2023Nationwide

Incisive CT Scanner (Philips) – Cable Disconnection Risk (2023)

If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.

FDADec 7, 2023AL, CA, CO +25 more• Philips North America

Baxter Vascular Probe (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Trevo Pro 18 Microcatheter (Stryker) – Unapproved Use (2023)

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

FDADec 6, 2023Nationwide• Stryker, Inc.

Peri-Guard Supple (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Peri-Guard Repair Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Baxter Ostene Hemostasis Material (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Accure Laser System (Accure) – Laser Energy Misalignment (2023)

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

FDADec 6, 2023CA, CO, CT +7 more• Accure Acne, Inc

Baxter Floseal Hemostatic Matrix (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Vascu-Guard Peripheral Vascular Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

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