Z-2479-2020Class II

BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or...

Name: Z-2479-2020 BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or...
Creator: Preventice Services, LLC
Published: 2019-08-06
License: https://open.fda.gov/license/

Preventice Services, LLC / initiated 2019-08-06 / Terminated / root cause: software

FDA source

Preventice Services, LLC began a recall of 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... on 2019-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2479-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Posted: 2020-07-01
Terminated: 2022-11-18
Recalling firm: Preventice Services, LLC
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.
Product code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: software
FDA 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 in commerce: 8 kits
Distribution: US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
Product codes and lots: Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2479-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2479-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-07-01

Product code DSI

K151188Class IIBodyGuardian Remote Monitoring SystemPreventice / cleared 2015-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)