GE Medical Systems Information Technologies Inc
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for GE Medical Systems Information Technologies Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-18FDA-DeviceClass IIMUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
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.
- 2024-07-10FDA-DeviceClass IIPrucka 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).
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.
- 2024-06-12FDA-DeviceClass IIGE 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 BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
- 2023-09-27FDA-DeviceClass IIPrucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
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.
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