Philips North America has recalled 301 Spectral CT and Spectral CT Plus systems running software version 5.0.X due to two critical software defects. One defect prevents the system's scan plan box from updating correctly during interventional procedures, which can cause the machine to collide with medical staff or needles inserted into a patient. The second issue involves software that may assign an incorrect patient ID to a scan, creating a risk of misdiagnosis. No injuries have been reported to date.
The software defects can lead to unintended physical contact between the scanning equipment and the operator or surgical tools inside a patient, potentially causing injury. Additionally, incorrect patient identification within the software can lead to patients being treated or diagnosed based on the wrong clinical data.
Total units affected: 301. Software version 5.0.X.
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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