Recall Z-2479-2020— Preventice Services, LLC
Class II · Terminated
Class II FDA medical device recall by Preventice Services, LLC, initiated 2019-08-06, terminated 2022-11-18. It names one FDA 510(k) clearance: K151188. 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.. Reason: 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..
- Recalling firm
- Preventice Services, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-06
- Terminated
- 2022-11-18
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.