Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871

FDA device recall Z-0719-2024 · posted 2024-01-12 · Open, Classified

Recall details

Recalling firm

Philips North America

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.

Action taken

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

JAK

Quantity affected

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.

Date initiated

2023-12-07

Date posted

2024-01-12

Location

Cambridge, MA

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