| 2026-07-10 |
Class II
|
Ongoing |
Z-2878-2026 |
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system |
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A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patien… |
| 2026-06-29 |
Class II
|
Ongoing |
Z-2876-2026 |
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph |
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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… |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2247-2026 |
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP… |
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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 … |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2246-2026 |
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in… |
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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 … |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2245-2026 |
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction … |
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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 … |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2244-2026 |
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet… |
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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 … |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2243-2026 |
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0… |
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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 … |
| 2026-04-24 |
Class II
|
Ongoing |
Z-2242-2026 |
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex… |
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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 … |
| 2025-04-25 |
Class II
|
Ongoing |
Z-1938-2025 |
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system … |
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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 … |
| 2024-04-22 |
Class II
|
Ongoing |
Z-2258-2024 |
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemody… |
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Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to … |
| 2024-04-09 |
Class II
|
Ongoing |
Z-2027-2024 |
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET… |
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Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
| 2023-08-08 |
Class II
|
Ongoing |
Z-2613-2023 |
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and Co… |
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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… |