GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex

FDA device recall Z-2242-2026 · posted 2026-05-28 · Open, Classified

Recall details

Recalling firm

GE Medical Systems Information Technologies Inc

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).

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

MHX

Quantity affected

476 units

Distribution

Worldwide distribution.

Date initiated

2026-04-24

Date posted

2026-05-28

Location

Waukesha, WI

Related 510(k) clearances