Philips Healthcare (Suzhou) Co., Ltd. recall Z-2988-2026 · FDA Recalls

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Class IIDeviceOngoing

Philips Healthcare (Suzhou) Co., Ltd.

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.

Details

Recall number: Z-2988-2026
Event ID: 99511
Recall initiated: Jun 26, 2026
Classified: Aug 21, 2026
Reported: Sep 2, 2026
Quantity: N/A
Distribution: U.S. Nationwide and U.S. Territories distribution.
Initiated by: FDA Mandated
Firm notification: N/A
Firm location: Suzhou, N/A, China
Lot / code info: Device Identifier: (01)00884838085015, (01)00884838105508.