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U.S. Department of Health and Human Services

Class 2 Device Recall BodyGuardian Heart Remote Monitoring Kit

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  Class 2 Device Recall BodyGuardian Heart Remote Monitoring Kit see related information
Date Initiated by Firm August 06, 2019
Create Date July 01, 2020
Recall Status1 Completed
Recall Number Z-2479-2020
Recall Event ID 85233
510(K)Number K151188  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
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.
Code Information Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
Recalling Firm/
Manufacturer
Preventice Services, LLC
1717 N Sam Houston Pkwy W Ste 100
Houston TX 77038-1324
For Additional Information Contact Mrs. Kimberly Hernandez
281-760-0500
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = PREVENTICE
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