# FDA recall Z-2988-2026

> **Philips Healthcare (Suzhou) Co., Ltd.** · Class II · device recall initiated 2026-06-26.

## Product

Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

## Reason for recall

Potential of failing to trigger clinical scan during Bolus Tracking.

## Distribution

U.S. Nationwide and U.S. Territories distribution.

## Key facts

- **Recall number:** Z-2988-2026
- **Recalling firm:** Philips Healthcare (Suzhou) Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-26
- **Report date:** 2026-09-02

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Suzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2988-2026

## Citation

> MORVS. FDA recall Z-2988-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-2988-2026. Source: US FDA. Licensed CC0.

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