Class 2 Device Recall PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3

• Date Initiated by Firm: September 11, 2018
• Create Date: December 07, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0584-2019
• Recall Event ID: 81077
• 510(K)Number: K120598 K133576 K151063 K130584
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3.; ; The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
• Code Information: All monitors
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: Mr. Ben Fox; 414-721-4013
• Manufacturer Reason for Recall: Patient monitors may restart due to network overload caused by network configuration.
• FDA Determined Cause: Software design
• Action: The recalling firm, GE Healthcare, issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 9/11/2018 via trackable mail on 9/11/2018 to its customers. The letters described the product, problem and actions to be taken. The letters informed the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Bx0 and/or B1x5 patient monitor on the network does not resume normal functionality in approximately 90 seconds. The customers were instructed to follow the safety instructions. GE Healthcare will provide revised network installation and user instructions documentation at no cost to you in a future mailing. 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: 33,065 patient monitors
• Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Brunei, Bulgaria, Burma (Myanmar), Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kampuchea, Kazakstan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Zambia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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