Z-0719-2024Class II

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

Name: Z-0719-2024 Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number...
Creator: Philips North America
Published: 2023-12-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-12-07 / Open, Classified / root cause: design

FDA source

Philips North America began a recall of Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 on 2023-12-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0719-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-12
Recalling firm: Philips North America LLC
Product: Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)