Category Archives: Biomedical Engineering

Hospira GemStar Infusion System Class I Recall

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Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE:  Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal … Continue reading

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Iradimed Corporation MRidium 3860 Infusion Systems Class 1 Recall

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Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class I Recall – Potential for Incorrect Recommended Infusion Rate AUDIENCE: Biomedical Engineering, Nursing, Radiology, Risk Manager ISSUE: FDA notified healthcare professionals … Continue reading

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CareFusion Alaris PC unit model 8015 Class I Recall

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CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall – Potential Loss of Communication Between Main Processor and Keyboard AUDIENCE: Risk Manager, Biomedical Engineer ISSUE: CareFusion has reported that if the Alaris PC unit model … Continue reading

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GE Healthcare Nuclear Medicine Systems Class I Recall

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GE Healthcare Nuclear Medicine Systems: Class I Recall – Serious Injuries or Deaths Could Occur [Posted 07/29/2013] AUDIENCE: Nuclear Medicine, Radiology, Risk Manager, Biomedical Engineering ISSUE: GE Healthcare became aware of an incident at a VA Medical Center facility in … Continue reading

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Cybersecurity for Medical Devices and Hospital Networks

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Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication AUDIENCE: Biomedical Engineering, Health Professional, Risk Manager ISSUE: FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to … Continue reading

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Maquet SERVO-i Ventilator Battery Module Class 1 Recall

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Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected AUDIENCE: Anesthesiology, Biomedical Engineering, Nursing, Risk Managers ISSUE:  Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This … Continue reading

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Covidien Surgical Stapler Reloads FDA Safety Communication

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Cardinal Health Various Presource Kits Class 1 Recall

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Cardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Manager, Surgery ISSUE: Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic … Continue reading

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Hospira Inc GemStar Infusion System Recall

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Hospira Inc., GemStar Infusion System: Recall – Lithium Battery Low Voltage Models 13000, 13100, 13150, 13086, 13087, 13088 AUDIENCE: Risk Manager, Biomedical Engineering, Nursing ISSUE: Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models … Continue reading

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GE Healthcare Giraffe OmniBed Giraffe Incubator Class I Recall

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GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall – Device May Randomly Delete Stored Information When Powered On AUDIENCE: Risk Manager, Biomedical Engineer ISSUE: The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new … Continue reading

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