Product does not have a failsafe and allowed for multiple patients to be given the same holter results.
Device did not record new data, just allowed to change demographics and when uploaded old patient information.
The new devices we have received from the company will blink red if old patient data is on the device.
The devices we were provided were flashing green like they were recording but did not just continue to hold old data not unique to the patient.
We have at least 39 patients involved.
Fda safety report id # (b)(4).
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