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GE Medical Systems Information Technologies Recalls
15 recalls on record · December 13, 2017 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Hazard: 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 (PHI).
August 12, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Hazard: 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 previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
June 10, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Hazard: 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 paper. Ignition of the paper could potentially result in serious thermal injury.
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP
Hazard: 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).
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in
Hazard: 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).
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction
Hazard: 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).
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet
Hazard: 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).
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0
Hazard: 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).
June 3, 2026Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex
Hazard: 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).
June 18, 2025Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system
Hazard: 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.
July 10, 2024Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemody
Hazard: 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.
June 12, 2024Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET
Hazard: Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
September 27, 2023Medical DevicesFDA
GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and Co
Hazard: 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.
February 7, 2018Medical DevicesFDA
GE Medical Systems Information Technologies, Inc. recalls GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to
Hazard: 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.
December 13, 2017Medical DevicesFDA
GE Medical Systems Information Technologies, Inc. recalls CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier so
Hazard: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.