FDA-Device2024-01-24Class II
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Philips North America
Hazard
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.
Sold states
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.
Affected count
55 US; 1029 ROW
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2024Don't want to check this manually?
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