Spacelabs Healthcare Inc - Spacelabs Healthcare CardioCall ECG Event Recorder - Class 2 Recall

Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The event recorder, called the CardioCall, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called Looping mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the Post-Activation mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the CardioConnect, is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

Source: Medical Device Recalls - October 30, 2015 Category: Medical Equipment Source Type: alerts