Recall Register

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GE Medical Systems Information Technologies Inc

FDA recalling firm · 12 enforcement events · 20 product records · 2017–2026 · WI

GE Medical Systems Information Technologies Inc has 12 FDA enforcement events on this register (20 product records) between 2017 and 2026: 12 device; the busiest year was 2026 with 6.

0% of its events are Class I; the most common class is Class II (12). 10 events are listed as ongoing; the recalling firm's address is in WI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Jul 2026Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STVDeviceClass II1Ongoing
20 Jul 2026PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209DeviceClass II4Ongoing
10 Jul 2026GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring systemDeviceClass II1Ongoing
29 Jun 2026GE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographDeviceClass II1Ongoing
24 Apr 2026GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)DeviceClass II6Ongoing
24 Apr 2026CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3DeviceClass II1Ongoing
25 Apr 2025MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.DeviceClass II1Ongoing
22 Apr 2024Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).DeviceClass II1Ongoing
9 Apr 2024GE 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; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB…DeviceClass II1Ongoing
8 Aug 2023Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.DeviceClass II1Ongoing
11 Jan 2018GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors…DeviceClass II1Terminated
13 Jul 2017CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care…DeviceClass II1Terminated

By type and class

Device12
Class II12

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for GE Medical Systems Information Technologies Inc by year initiated.

Questions and answers

How many FDA recalls has GE Medical Systems Information Technologies Inc had?

12 enforcement events (20 product records) on this register, 2017–2026: 12 device.

Are any GE Medical Systems Information Technologies Inc recalls ongoing?

10 events are listed as ongoing in the current openFDA export.

What class are GE Medical Systems Information Technologies Inc recalls?

12 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.