FDA recall Z-2988-2026

Philips Healthcare (Suzhou) Co., Ltd. · Class II · device

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

Status
Ongoing
Initiation date
2026-06-26
Report date
2026-09-02
Voluntary/Mandated
FDA Mandated
Location
Suzhou, N/A, China

Primary source

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