Reported Jul 8, 2020 · Terminated
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and…
Preventice Services, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preventice Services, LLC · 1717 N Sam Houston Pkwy W Ste 100 · Houston, TX · 77038-1324
Is this the product you have?
- 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.
- Lot codes and dates
Version 2.3 phone softwarekit IDs BG2570727BG2565845BG2567817BG2566832BG2566830BG2570699BG2566530and BG2570700
- Amount recalled
- 8 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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