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• Class I Medical Device Recall: Ikaria INOmax DS Drug Delivery System - Reason for Recall: Fretting corrosion at the electrical contact interface of certain metals was the root cause for erratic nitric oxide (NO) monitoring readings. Adverse consequences may include inadequate oxygen reaching the tissues in the body...
• Class I Medical Device Recall: Respironics, Inc. Trilogy 100 Ventilators - Trilogy 100 ventilators are being recalled due to a manufacturing issue. This issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy..
• Consumer Information on: ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems - P100039 - ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.
• Consumer Information on: BSD-2000 Hyperthermia System - H090002 - The BSD-2000 Hyperthermia System is intended to deliver focused therapeutic heating (hyperthermia); with temperatures greater than 104 Fahrenheit (40 Celsius), to cancerous tumors by applying radiofrequency (RF) energy at the frequency range of 75 to...
• Consumer Information on: Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004 - The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..
• Consumer Information on: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer - P110031 - The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria...
• Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040 - The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...
• Consumer Information on: M-Vu Algorithm Engine - P100005 - The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o