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Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part ...

FDA Recall #Z-0719-2024 — Class II — December 7, 2023

Recall #Z-0719-2024 Date: December 7, 2023 Classification: Class II Status: Ongoing

Product Description

Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871

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.

Recalling Firm

Philips North America — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

55 US; 1029 ROW

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.

Code Information

Incisive CT systems configured with the PIM cable option are affected by this issue. To determine whether your system is affected, please locate the connection cable between your ECG monitor and incisive CT gantry and verify that the part number on your PIM cable matches 459801179871 . (1) REF 728143 - UDI-DI 00884838085015 Serial Numbers: 33007 33038 33013 33006 33012 33045 33011 500102 33015 33005 33041 33047 500217 500255 33035 500252 500145 500046 500168 33009 33046 33024 500222 500064 33034 500242 500301 33010 33019 33001 33020 33031 33037 500110 500111 500178 33003 500282 33002 33033 (2) REF 728144 - UDI-DI 00884838105508 Serial Numbers: 34002 34051 34050 34041 34059 34057 34054 34040 34007 34026 34058 34049 34056 34052

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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