GE Healthcare announced a Class I recall of Single-Width Airway Modules (E-MiniC), and Accessories and Extension Modules (N-FC, N-FCREC). These devices are used in hospitals and other health care facilities to monitor CO2 and respiration rates in patients weighing >11 pounds (5kg).
The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians who make decisions based on incorrect values may cause permanent, irreversible impairment or life-threatening changes in patients such as hypoventilation, hypercapnia, or death from low CO2 levels.
The affected products are Single-Width Airway Modules (E-miniC), serial numbers 6818561–6898777, the Extension Modules N-FC and N-FCREC, serial numbers 6799191–6905206. Modules serviced with FRU (Field Replaceable Unit) catalog number M1013204 (miniC Unit, N-FCREC) between February 2012 and May 2014 may also be affected by this recall.
Products affected by the recall were manufactured between February 10, 2012 through October 2, 2012 and distributed February 2012 to April 2014.
For more information and a complete listing of affected serial and module numbers visit the FDA Safety Alert page.