Preventice Services, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Preventice Services, LLC
Lot Codes / Batch Numbers
Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
Products Sold
Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
Preventice Services, LLC is recalling BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001 due to The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone softwar. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026