medical Class II Updated 2020-07-08

Preventice Services, LLC recalls BodyGuardian Heart Remote Monitoring Kit, consisting of two

Recalled Product

BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.


Hazard / Issue

The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, therefore, the patient's report should not be used to evaluate their condition.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
View official government recall

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