BodyGuardian Heart Remote Monitoring Kit — Class II medical device recall Z-2479-2020
Terminated recall by Preventice Services, LLC, reported 2020-07-08, distributed nationwide. The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidat
| Recall number | Z-2479-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preventice Services, LLC, Houston, TX, United States |
| Recall initiated | 2019-08-06 |
| Classified | 2020-07-01 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 8 kits |
| Reason classes | software |
| Model numbers | BC-1001-A, BC1001-D, BP10014, BP1008 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2479-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.