# FDA recall Z-0719-2024

> **Philips North America** · Class II · device recall initiated 2023-12-07.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-0719-2024
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-07
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2024

## Citation

> AI Analytics. FDA recall Z-0719-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0719-2024. Source: US FDA. Licensed CC0.

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