PlainRecalls
ModerateClass IITerminated

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…

Recall #
Z-2479-2020
Affected scope
8 kits
Initiated
August 6, 2019
Compiled from official public sources by the editorial team.
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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 FDA Devices action (record #Z-2479-2020) was formally reported on July 8, 2020, with the manufacturer initiating the action on August 6, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Preventice Services, LLC is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 8 kits.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.. Distribution scope 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 - 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 - 40,422 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,256

Where this recall sits in the database

Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.

Severity

Moderate

Affected scope

8 kits

Related Recalls

6

0 from same agency

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

Structured summary of the FDA Devices recall record
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.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Preventice Services, LLC. Units affected: 8 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2479-2020.
Where was the recalled product distributed?
Distribution: US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2479-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 8, 2020.

  • Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.