Device recall

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

FDA recall source

Recall number

Z-2988-2026

Event id

99511

Status

Ongoing

FDA classification

Class II

Recalling firm

Philips Healthcare (Suzhou) Co., Ltd.

Report date

Sep 2, 2026

Posted

Aug 21, 2026

Initiated

Jun 26, 2026

Center classification date

Aug 21, 2026

Product code

JAK

Device type

System, X-Ray, Tomography, Computed

Reason

Potential of failing to trigger clinical scan during Bolus Tracking.

Root cause

Radiation Control for Health and Safety Act

Quantity

N/A

Code info

Device Identifier: (01)00884838085015, (01)00884838105508.

Distribution

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

Voluntary or mandated

FDA Mandated

Related 510(k)s

K212441

Location

Suzhou, N/A, China