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Category: Product Recalls

Must-Read Insights

Philips Corrects Outpatient Monitoring Software Over Missed ECG Alerts

Philips Corrects Outpatient Monitoring Software Over Missed ECG Alerts

The correction addresses a software issue in the Monitoring Service Application that led to missed ECG data and notifications, potentially impacting patient care.

  • Most Recalled Cardiovascular Devices Lacked Clinical Testing

    Most Recalled Cardiovascular Devices Lacked Clinical Testing

  • Abbott Recalls HeartMate LVADs After Multiple Deaths

    Abbott Recalls HeartMate LVADs After Multiple Deaths

  • Impella Heart Pumps Linked to 49 Deaths

    Impella Heart Pumps Linked to 49 Deaths

  • Abbott Recalls HeartMate Touch System Over Risk of Unintended Pump Stops

    Abbott Recalls HeartMate Touch System Over Risk of Unintended Pump Stops

  • Getinge ECMO Device Recalled Due to Critical Malfunction Risks

    Getinge ECMO Device Recalled Due to Critical Malfunction Risks

  • Cardiosave Intra-Aortic Balloon Pumps Recalled for Unexpected Shutdowns

    Cardiosave Intra-Aortic Balloon Pumps Recalled for Unexpected Shutdowns

Staff's Top Picks

FDA Recommends Alternative Testing Methods for Quidel’s Triage Cardiac Panel

FDA Recommends Alternative Testing Methods for Quidel’s Triage Cardiac Panel

The FDA cautions health providers to stop using the Quidel Triage Cardiac Panel due to potential inaccuracies in troponin levels. Alternatives are recommended to ensure accurate diagnoses for myocardial infarction.

  • Medtronic Issues Class I Recall for Implantable Cardioverter Defibrillators and CRT-Ds

  • Quidel’s Cardiac Testing Panels Recalled: A Severe FDA Warning Over Potential Fatal Risks

  • Abiomed Recalls Impella 5.5 Left Ventricular Device Systems: Urgent Action Required to Address Product Leakage

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