FDA Medical Device Recalls (openFDA)
Preventice Services, LLC: 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.
- Recall number
- Z-2479-2020
- Recalling firm
- Preventice Services, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-08-06
- Posted
- not on file
- Terminated
- 2022-11-18
- Reason
- 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.
- Root cause
- Software design (manufacturing process)
- Action
- On 8/6/2019, the recalling firm contacted or attempted to contact by phone all patients that had potentially impacted devices. Phone communication to the physicians of the patients also began on 8/6/2019. All patients that agreed were sent new devices to replace the affected one to finish their study.
- Quantity
- 8 kits
- Distribution
- US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
- 510(k) numbers
- ["K151188"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 3005332083
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28