BodyGuardian Heart Remote Monitoring Kit recall: Software Issue
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…
Why was BodyGuardian Heart Remote Monitoring Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.
- 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…
- Recalling firm
- Preventice Services, LLC
- Quantity
- 8 kits
- Distribution
- US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)