Ge Medical Systems Information Technologies recalls
Ge Medical Systems Information Technologies appears in 20 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 20 |
|---|---|
| Published | 2017-12-13 to 2026-09-23 |
| By agency | FDA Device (20) |
| By classification | Class II (20) |
| By status | ongoing (18), terminated (2) |
| Distribution named in notices | CA, CO, FL, GA, IL, IN, KY, MA, MI, NC, NJ, NY, OH, OR, PA, SC, TX, US, VA, WI |
Recalls
- Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number…
FDA Device · Class II · 2026-09-23 · Ge Medical Systems Information Technologies
Reason: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. - PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings pre… - PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings pre… - FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings pre… - PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings pre… - GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
FDA Device · Class II · 2026-08-12 · Ge Medical Systems Information Technologies
Reason: A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PH… - GE Healthcare MAC VU360, REF# part number 2030361-023
FDA Device · Class II · 2026-08-12 · Ge Medical Systems Information Technologies
Reason: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a pre… - CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
FDA Device · Class II · 2026-06-10 · Ge Medical Systems Information Technologies
Reason: Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer… - GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
Reason: 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 NETWO… - MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses store…
FDA Device · Class II · 2025-06-18 · Ge Medical Systems Information Technologies
Reason: The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data. - Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electroph…
FDA Device · Class II · 2024-07-10 · Ge Medical Systems Information Technologies
Reason: Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms. - GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX
FDA Device · Class II · 2024-06-12 · Ge Medical Systems Information Technologies
Reason: Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. - Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX
FDA Device · Class II · 2023-09-27 · Ge Medical Systems Information Technologies
Reason: A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. - GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from…
FDA Device · Class II · 2018-02-07 · Ge Medical Systems Information Technologies
Reason: CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart. - CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is i…
FDA Device · Class II · 2017-12-13 · Ge Medical Systems Information Technologies
Reason: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.