Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4.5&V5.0
Reason for recall
Potential of failing to trigger clinical scan during Bolus Tracking.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Lot / code information
Device Identifier: (01)00884838085015, (01)00884838105508.
What the firm is doing
Philips notification dated June 26, 2026 will inform customers of the issue via an Electronic Product Radiation Correction notification. Philips will schedule an appointment with customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2026-PD-CTAMI-108.
DistributionShow detailsHide
U.S. Nationwide and U.S. Territories distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2988-2026
- FDA 510(k) clearance · K212441The device's official FDA premarket clearance record
- FDA device classification · JAKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1750The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips Healthcare (Suzhou) Co., Ltd.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
- C-Reactive Protein Test System
- Under Investigation by firm
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the pl…
- Bone Fixation Plate
- Process control
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿
Due to incorrect inside packaging label for eyepiece.
- Nasopharyngoscope (Flexible Or Rigid)
- Employee error