Incisive CT recallZ-0719-2024 · Philips North America · initiated Dec 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
On December 7, 2023, the firm notified affected customers through URGENT Medical Device Correction Notice letters. Customers were informed that they may continue to use their Philips Incisive CT system in accordance with the intended use. However, to minimize the potential for loss of the ECG signal, customers should avoid frequently plugging and unplugging the PIM cable. In case of a connection failure, contact your local service representative and reference FCO72800782. Philips will contact you to schedule time for a Field Service Engineer to visit your site to replace the PIM cable with an upgraded version. If you need additional information or support concerning this issue, please contact Philips' Customer Care Solutions Center at 1-800-722-9377.
Recall details
- Recall number
- Z-0719-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Philips North America
- Quantity
- 55 US; 1029 ROW
- Product code
- JAK
- FDA submissions
- K212441, K180015
- 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.
Product description
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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