Medical Device Safety and Recalls: GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) - CO2 Detector May Fail Leading to Injury

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 25 Jul 2014 12:24:33 -0500

Title:     Medical Device Safety and Recalls: GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) - CO2 Detector May Fail Leading to Injury

  A recall has been issued for the GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC).  The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.  Patients may experience an inadequate exchange of gases (hypoventilation), causing an increased concentration of CO2 (hypercapnia). Death may also occur as a result of low CO2 values.  There are no reports of injuries or deaths associated with the malfunctioned devices.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm406734.htm

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