FDASeptember 3, 2015device
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
What to do
FDA enforcement status: Terminated
Brands named
spacelabs healthcarespacelabs
Recall history
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