FDAFDA · Food and drugs·Recall number Z-2988-2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Published September 2, 2026 · Recall initiated: June 26, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential of failing to trigger clinical scan during Bolus Tracking.
What to do
FDA Mandated
Recall details
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- Distributor
- U.S. Nationwide and U.S. Territories distribution.
- Lot
- Device Identifier: (01)00884838085015, (01)00884838105508.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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