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Medical Product Safety Alert > ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working

The FDA has just issued a Class I recall for ARKON Anesthesia delivery systems.  The software, produced by Spacelabs Healthcare, has a defect that can cause the system to cease providing ventilation for patients, which can cause serious health consequences, including hypoxemia or death.  87 more words

Dangerous Products

Class I Recall Alert: Oxygen Resuscitation System for Newborns, GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly

The FDA just announced a Class I Recall for GE Healthcare Resuscitation Systems typically used for newborns.  The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly, causing interference with oxygen delivery.  58 more words

Dangerous Products

FDA Class 1 Recall > ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port with and without Preloaded Stylet by Teleflex Medical: Potential Kinking During Patient Use

The FDA has just issued a Class I Recall of the Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The affected tracheal tube may kink during patient use, which can deprive the patient of air and cause serious injury, including hypoxic brain injury, anoxic brain injury, or death. 136 more words

Brain Injury