Recall archive / FDA device enforcement
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. — FDA record Z-2988-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 26, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Reason
- Potential of failing to trigger clinical scan during Bolus Tracking.
- Classification
- Class II
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2988-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Device Identifier: (01)00884838085015, (01)00884838105508. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide and U.S. Territories distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 2, 2026
- Recall initiation date
- Jun 26, 2026
- Center classification date
- Aug 21, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.