Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…

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Editor's Note The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing. The drain is being recalled by maker Maquet Cardiovascular,…

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Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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Editor's Note The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious. The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the…

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Editor's Note The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious. The recall was initiated because the catheters’ instructions for use did not appropriately address precautions…

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Editor's Note The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious. The recall was initiated after detecting dust and dirt from the environment in the air path…

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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…

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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…

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