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Tag Archives: Anesthesiology
Maquet SERVO-i Ventilator Battery Module Class 1 Recall
Translation 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. … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Anesthesiology, Battery Module, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA recall, Maquet, Maquet SERVO-i Ventilator Battery Module Class 1 Recall, Nursing, Recall, Risk Managers, SERVO-i Ventilator
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Cardinal Health Various Presource Kits Class 1 Recall
TranslationCardinal 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
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged Anesthesiology, Biomedical Engineering, Cardinal Health, Cardinal Health Various Presource Kits Class 1 Recall, Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Surgery, Various Presource Kits
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Spacelabs Anesthesia Workstations Service Kits Class 1 Recall
TranslationSpacelabs Anesthesia Workstations and Service Kits: Class 1 Recall – Defect in CAS I/II Absorbers AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Managers ISSUE: There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager
Tagged Anesthesia, Anesthesiology, Biomedical Engineering, Class 1 Recall, Class I Recall, drug risks, FDA recall, Recall, Risk Managers, Service Kits, Spacelabs, Spacelabs Anesthesia Workstations Service Kits Class 1 Recall, Workstations
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Hamilton Medical Inc HAMILTON T1 Ventilators
TranslationHamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower AUDIENCE: Anesthesiology, Risk Managers ISSUE: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 … Continue reading
Posted in Anesthesiology, FDA 2013, FDA Safety Communication, FDA Warning, Risk Manager
Tagged Anesthesiology, Drug Safety Communication, FDA notice, FDA warning, Hamilton Medical Inc, Hamilton Medical Inc HAMILTON T1 Ventilators, HAMILTON T1, Risk Managers, Safety Communication, Ventilators
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Ventlab Adult and Pediatric Manual Resuscitators Recall
TranslationVentlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient Audience: Risk Manager, Anesthesiology ISSUE: The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Recall, Risk Manager
Tagged Anesthesiology, Pediatric Manual Resuscitators, Recall, Risk Manager, Ventlab Adult, Ventlab Adult and Pediatric Manual Resuscitators Recall
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Accutron Inc Flowmeters Class 1 Recall
TranslationAccutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall – Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off AUDIENCE: Anesthesiology, Dentistry, Risk Manager ISSUE: Accutron voluntarily recalled … Continue reading
CareFusion Airlife Infant Breathing Circuit Class I Recall
TranslationCareFusion Airlife Infant Breathing Circuit: Class I Recall – Potential for Leak in Closed Ventilation System AUDIENCE: Anesthesiology, Risk Manager ISSUE: FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk … Continue reading