Medical Device Recall: Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Philips North America · December 7, 2023
Reason for Recall
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.
Distribution
Domestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY LA MD MI MO MS ND NE NJ NY OH OK PA RI SC TX UT VT WA International distribution worldwide.
States Affected
AL, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MI, MO, MS, ND, NE, NJ, NY, OH, OK, PA, RI, SC, TX, UT, VT, WA
Quantity Affected
55 US; 1029 ROW
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0719-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.