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.
FDA Recall Z-2479-2020 · Posted None
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Recalling FirmPreventice Services, LLC
Recall StatusTerminated
Product CodeDSI
Date Initiated2019-08-06
Date Terminated2022-11-18
Product Quantity8 kits
Reason for Recall
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.
Firm Action
On 8/6/2019, the recalling firm contacted or attempted to contact by phone all patients that had potentially impacted devices. Phone communication to the physicians of the patients also began on 8/6/2019. All patients that agreed were sent new devices to replace the affected one to finish their study.
Root Cause
Software design (manufacturing process)
Distribution Pattern
US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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