Voluntary Field Corrective Action Issued for GE Healthcare’s CARESCAPE Respiratory Modules and Airway Gas Option

CHICAGO, IL – December 20, 2019 - GE Healthcare is issuing a voluntary field action for certain CARESCAPE Respiratory Modules and Airway Gas Options and their respective service exchange units and field replaceable units that are used with certain GE Healthcare monitors, anesthesia and respiratory devices. The company is taking this action after internally identifying approximately 800 products of which a small number may have had a soldering step omitted during the manufacturing process. This possible issue could potentially cause the O2 sensor inside the Respiratory Module or Airway Gas Option to fail.

The potentially affected CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) were manufactured or repaired between June 7, 2019 – Aug. 16, 2019 and are compatible with the following GE Healthcare host systems:

CARESCAPE B850, B650 and B450 Patient Monitors B40(i), B105, B125 Patient Monitors Avance CS2 and Aisys CS2 Anesthesia Carestation Carestation 620, 650, 650c for Anesthesia CARESCAPE R860 Ventilator for Critical Care S/5 modular monitors

The potentially affected Airway Gas Option (N-CAiO) are compatible with the following GE Healthcare host devices:

B40(i), B105, B125 Patient Monitors Carestation 620, 650, 650c for Anesthesia

GE Healthcare has conducted a thorough investigation and determined that this issue is highly unlikely to be present. As a precautionary measure, the company is notifying all users that if a failure occurs, the monitor could potentially display an inaccurate oxygen level and not the correct level that is being administered to the patient and selected by the clinician.

The company will replace the affected product at no cost to customers. Until replacements are received, users of these systems are instructed to replace affected products with non-affected products from their existing inventory when possible. A list of all potentially affected serial numbers is available at https://www.gehealthcare.com/September2019.

If a user does not have non-affected products for use as a replacement, the company is providing instructions for how to test their affected product to ensure that the oxygen reading is within specifications. These instructions are available at https://www.gehealthcare.com/September2019.

For additional information regarding this field action, or to report complaints or adverse events involving these products to GE Healthcare, please contact GE Healthcare’s Customer Service line (24 hours a day, 7 days a week) at 800-437-1171. Maintaining a high level of safety and quality is our highest priority.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or email), or via phone at 1-800-FDA-1088.