Terumo Cardiovascular Systems has voluntarily recalled 37 units of the Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe (Catalog Number CD1754). During clinical procedures, medical staff observed that oxygen saturation (SO2) values may periodically disappear from the display, showing as dashes instead of numerical values. While this event triggers a yellow low-limit alarm to warn the user, the missing data indicates that monitoring values are temporarily unavailable. No incidents or injuries have been reported to date.
The display of unavailable or dashed-out oxygen saturation data during medical procedures could lead to clinicians lacking critical real-time information. While an alarm sounds to alert staff, the temporary loss of data could impact clinical decision-making during sensitive cardiovascular monitoring.
Units were directly distributed to clinical facilities.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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