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.
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: 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. Quantity: 55 US; 1029 ROW Lot/code info: 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
459801179871, 00884838085015, 00884838105508
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.