Class 1 Device Recall CARESCAPE R860 Inspiratory Safety Guard

• Date Initiated by Firm: October 05, 2018
• Date Posted: November 30, 2018
• Recall Status: Terminated on April 29, 2024
• Recall Number: Z-0463-2019
• Recall Event ID: 81341
• 510(K)Number: K142679
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers:; a) 2066713-001 (single pack); b) 2083208-001 (box of ten singles); ; The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
• Code Information: a) 2066713-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130 b) 2083208-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 800-437-1171
• Manufacturer Reason for Recall: The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
• FDA Determined Cause: Process control
• Action: The firm, GE Healthcare, initiated an "URGENT MEDICAL DEVICE CORRECTION" on 10/05/2018 by letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Follow the safety instructions and If you have any incorrect ISGs, return to GE Healthcare or destroy on site, and complete and return the attached Customer Response form checking box #2 to indicate that you do have affected ISGs. E-mail the completed form to Recall34095.InspiratorySG@ge.com. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. 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. The firm initiated a new recall notice identifying a new issue on 02/01/2019
• Quantity in Commerce: 1140 units (307 units in US)
• Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Honduras, Hungary, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
• 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 = CBK and Original Applicant = Datex-Ohmeda, Inc.