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GE Medical Systems Information Technologies Inc

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph recall (Z-2876-2026)GE Medical Systems Information Technologies Inc2026-08-04
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 recall (Z-2878-2026)GE Medical Systems Information Technologies Inc2026-08-04
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 recall (Z-2279-2026)GE Medical Systems Information Technologies Inc2026-06-01
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; recall (Z-2242-2026)GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by G recall (Z-2243-2026)GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code recall (Z-2244-2026)GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product recall (Z-2245-2026)GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603- recall (Z-2246-2026)GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in con recall (Z-2247-2026)GE Medical Systems Information Technologies Inc2026-05-28
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client recall (Z-1938-2025)GE Medical Systems Information Technologies Inc2025-06-10
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording sy recall (Z-2258-2024)GE Medical Systems Information Technologies Inc2024-07-03
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, recall (Z-2027-2024)GE Medical Systems Information Technologies Inc2024-06-06
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, use recall (Z-2613-2023)GE Medical Systems Information Technologies Inc2023-09-19
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Centra recall (Z-0487-2018)GE Medical Systems Information Technologies, Inc.2018-01-25

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Every clearance here is in the API, with alerts when new ones post.