Class 1 Device Recall Airway Gas Option NCAiO

• Date Initiated by Firm: September 27, 2019
• Date Posted: January 10, 2020
• Recall Status: Terminated on September 26, 2023
• Recall Number: Z-0760-2020
• Recall Event ID: 84034
• 510(K)Number: K133576
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: Airway Gas Option N-CAiO
• Code Information: Mfg. Lot or Serial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
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
• FDA Determined Cause: Process control
• Action: The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: 1) Connect the module to the host device; 2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes; 3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions; 4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and 5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform. 6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. Contact GE Healthcare Service or your local Service Representative. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 12 units
• Distribution: US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CCK and Original Applicant = GE MEDICAL SYSTEMS CHINA CO., LTD.