Z-2479-2020 Class II Terminated
FDA device recall Z-2479-2020 was initiated by Preventice Services, LLC on August 6, 2019 and is designated Class II. 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… The recall status is terminated (terminated November 18, 2022). Affected quantity: 8 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- August 6, 2019
- Termination Date
- November 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 kits
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.
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.
Distribution Pattern
US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
Code Information
Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.