FDA: Class I recall of Baxter SIGMA Spectrum, Spectrum IQ infusion pumps
Editor's Note The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious. The recall…
FDA: Class I recall of GE HealthCare’s TruSignal SpO2 sensors
Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…
FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps
Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…
FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath
Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…
Navigating challenges of connecting recalls to patients, inventory
Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…
FDA: Class I recall of Quidel Triage Cardiac Panels
Editor's Note The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious. The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators
Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…
FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators
Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…
FDA: Class I recall of Megadyne’s Mega 2000, Mega Soft reusable patient return electrodes
Editor's Note The Food and Drug Administration (FDA), on July 11, identified the recall by Megadyne of its Mega 2000 and Mega Soft reusable patient return electrodes as Class I, the most serious. The recall was initiated after Megadyne received reports of pediatric and adult patients receiving burn injuries during…
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