Recall Z-2479-2020
Preventice Services, LLC · initiated August 6, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
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: Software design (manufacturing process)
Action taken
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.
Details
- Recall number
- Z-2479-2020
- Initiated
- August 6, 2019
- Terminated
- November 18, 2022
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Quantity
- 8 kits
- Distribution
- US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
- Recalling firm
- Preventice Services, LLC, Houston, TX