Terumo Cardiovascular Systems Corporation has issued a recall for 28 units of the CDI OneView System BPM Probes (Catalog Numbers CDI753 and CDI753TK) in the United States. An assembly error involving the device's thermistor can cause the probe to provide inaccurate temperature measurements and other critical blood gas data. These inaccurate readings may lead healthcare providers to make inappropriate treatment decisions during surgery. No incidents or injuries have been reported to date.
The affected probes may provide inaccurate data for temperature and other parameters like oxygen, pH, and potassium levels. Using these incorrect measurements to manage a patient during surgery could result in inappropriate medical responses, potentially causing serious patient harm.
Quantity affected: 28 in US, 7 Outside US.
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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