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.

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.