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

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

Recall Summary

Recall Number Z-0719-2024
Classification Class II — Moderate risk
Date Initiated December 7, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America
Location Cambridge, MA
Product Type Devices
Quantity 55 US; 1029 ROW

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.

Distribution Pattern

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.

Lot / 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

Other Recalls from Philips North America

Recall # Classification Product Date
Z-1966-2026 Class II Philips SmartPath to dStream for 3.0T with MR E... Apr 14, 2026
Z-1955-2026 Class II Philips Evolution upgrade 3.0T with MR Elastogr... Apr 14, 2026
Z-1960-2026 Class II Philips Ingenia Ambition S with MR Elastography... Apr 14, 2026
Z-1968-2026 Class II Philips SmartPath to Ingenia Elition X with MR ... Apr 14, 2026
Z-1958-2026 Class II Philips Ingenia 3.0T with MR Elastography (MRE)... Apr 14, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.