GE Medical Systems is recalling 145 Prucka 3 Amplifiers used with CardioLab and ComboLab recording systems. Certain capacitors in these amplifiers can fail, causing the screen to display wavy lines and preventing medical professionals from viewing critical surface and intracardiac ECG waveforms. These devices are used in electrophysiology and hemodynamic recording procedures where clear waveform visibility is essential for patient monitoring. Consumers should contact GE Medical Systems Information Technologies Inc or their healthcare provider for further instructions regarding this equipment.
The failure of internal capacitors causes transient oscillations on the display, making it impossible for clinicians to monitor the patient's heart activity (ECG) during medical procedures. This loss of visualization can delay or disrupt cardiac assessments and treatments.
Contact healthcare provider or manufacturer
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Sources: FDA iRES · Raw API Response
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