Preventice Services, LLC: Medical Device Recall in 2020 - (Recall #: Z-2479-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 6, 2019

Date Posted: July 8, 2020

Recall Number: Z-2479-2020

Event ID: 85233

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.

Status: Terminated

Product Quantity: 8 kits

Code Information:

Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.

Distribution Pattern:

US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated