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GE Medical Systems Information Technologies Inc FDA Recalls
18 recalls on file across devices, 0 of them Class I and 18 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAIClass IIJul 30, 2026Device may not resume patient monitoring for at least 3 minu |
| PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353Class IIJul 20, 2026Software issue may result in a loss of patient monitoring at |
| PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209Class IIJul 20, 2026Software issue may result in a loss of patient monitoring at |
| FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225Class IIJul 20, 2026Software issue may result in a loss of patient monitoring at |
| PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592Class IIJul 20, 2026Software issue may result in a loss of patient monitoring at |
| GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring systemClass IIJul 10, 2026A software vulnerability may allow unauthorized persons to g |
| GE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographClass IIJun 29, 2026Software issue issue with the MAC VU360 v3.0 system. After |
| GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used inClass IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPClass IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3Class IIApr 24, 2026Electrical sparking may occur at the printer head. If the El |
| GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexClass IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction Class IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE TelemetClass IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0Class IIApr 24, 2026GE HealthCare has become aware of an unlikely situation wher |
| MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system Class IIApr 25, 2025The MUSE Administrator Account active directory or local cre |
| Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodyClass IIApr 22, 2024Capacitors in certain Prucka 3 Amplifiers used with CardioLa |
| GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONETClass IIApr 9, 2024Use of the blood pressure cuffs could result in inaccurate n |
| Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and CoClass IIAug 8, 2023A diode on the power supply of the Prucka 3 Amplifier used w |