OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as fda mandated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Philips Healthcare (Suzhou) Co., Ltd.
Reason
Potential of failing to trigger clinical scan during Bolus Tracking.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
U.S. Nationwide and U.S. Territories distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99511…

Products

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

    Codes/lots: Device Identifier: (01)00884838085015, (01)00884838105508.Quantity: N/ARecall no. Z-2988-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls