Preventice BodyGuardian Heart Remote Monitoring Kit Recalled for Data Accuracy Issues
Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where inaccurate data could lead to improper medical evaluation, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Preventice Services, LLC is recalling eight BodyGuardian Heart Remote Monitoring Kits. Each kit consists of two BG Heart monitors (Models BC-1001-A or BC1001-D) and a paired cell phone (Models BP1008 or BP10014). The affected kits are identified by Version 2.3 phone software and specific kit IDs: BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
The recall is due to a nonvalidated association between the phone software and the heart monitors, which may result in inaccurate data collection and transfer to the monitoring center. Consequently, the patient's report generated by the device should not be used to evaluate their medical condition.
The affected kits were distributed nationwide to Alaska, Alabama, Georgia, New Jersey, Ohio, and Texas. There was no foreign, military, or government distribution. Consumers should stop using the device for medical evaluation and contact the recalling firm for instructions.
The recalled product
- 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.
- Manufacturer
- Preventice Services, LLC
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Version 2.3 phone software
- kit IDs BG2570727
- BG2565845
- BG2567817
- BG2566832
- BG2566830
- BG2570699
- BG2566530
- and BG2570700.
Distribution
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