Baxter Healthcare is issuing an urgent medical device correction for 89 units of its Epiphany Cardio Server E3 ECG Management System software, specifically versions v6.1.x, v6.2.x, and v7.0.x. The recall was initiated because the caliper tool—used for measuring heart rhythms—can become non-responsive and temporarily stop working. This defect was identified after a report of the tool failing during use. Consumers should contact their healthcare provider or Baxter Healthcare for instructions on how to address this software issue.
A non-responsive caliper tool prevents clinicians from making precise cardiac measurements on an ECG, which could lead to delays in diagnosis or clinical decision-making during heart monitoring. One incident of the tool becoming non-responsive has been reported.
Urgent Medical Device Correction/Software Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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