Philips North America Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Brand
Philips North America
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Philips North America is recalling Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part numbe due to If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MI, MS, MO, NE, NJ, NY, ND, OH, OK, PA, RI, SC, TX, UT, VT, WA
Page updated: Jan 10, 2026