Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–6 of 6 recalls
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System..…