FDA Devices recall · Reported July 8, 2020
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.
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, the…
Preventice Services, LLC recalled BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Mod… - a moderate-severity action.
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Mod… was recalled by Preventice Services, LLC in July 8, 2020. Reason: The device data being collected and transferred to the monitoring center may not be accurate due to nonvalida…. Check the official notice for the remedy. Verify recall #Z-2479-2020 with the FDA Devices before acting.
The recall
Preventice Services, LLC issued this moderate-severity FDA Devices recall-The device data being collected and transferred to the monitoring center may not be accurate due to nonvalida….
- Moderate
- severity level
- Class II
- classification
- July 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2479-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2479-2020 |
| Date reported | July 8, 2020 |
| Date initiated | August 6, 2019 |
| Recalling firm | Preventice Services, LLC |
| Firm location | Houston, TX |
| Affected scope | 8 kits |
| Distribution | US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2479-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026