Class 2 Device Recall GE HealthCare

• Date Initiated by Firm: April 24, 2026
• Date Posted: May 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2243-2026
• Recall Event ID: 98938
• 510(K)Number: K103142
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
• Code Information: UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.
• FEI Number: 3001570235
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies Inc; 3114 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
• FDA Determined Cause: Software design
• Action: GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 4/24/2026 by letter using a traceable means. The notice explained the the safety issue pertaining to the persistent NO COMM or OFF NETWORK condition, and provided instructions for the safe use of the device should either issue arise. "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your ApexPro CTS with Central Station for telemetry only or combination monitoring unless you observe a persistent (more than a few seconds) NO COMM or OFF NETWORK notification. If you do observe a persistent NO COMM or OFF NETWORK notification, follow the instructions below. 1. Use alternative bedside patient monitoring to ensure continuous clinical surveillance until the NO COMM or OFF NETWORK condition is resolved by GE HealthCare. NOTE: If you are using combination monitoring, it is recommended to switch ECG monitoring to the bedside monitor. 2. Immediately notify your Facility s Biomedical Engineering, IT or Service Department and contact GE HealthCare Service. 3. Verify monitoring is restored at the Central Station(s) and/or bedside monitor(s). Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please post this notification by your Central Station(s). Please retain this document for your records." "GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 14 units
• Distribution: Worldwide distribution.
• 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