Recall Z-2479-2020 ยท DSI Detector And Alarm, Arrhythmia
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.
| Date | Aug 6, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| 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. |
| Quantity | 8 kits |
| Distribution | US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151188 | BodyGuardian Remote Monitoring System Preventice, Sep 17, 2015 |