FDAFDA recall Z-2988-2026 · Sep 2, 2026
Philips Healthcare (Suzhou) Co., Ltd.: Philips Incisive CT with software V4 recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Device Identifier: (01)00884838085015, (01)00884838105508.
- Quantity
- N/A
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd., Suzhou, N/A
- Voluntary or mandated
- FDA Mandated
- Recall started
- 2026-06-26
Source: openFDA enforcement record Z-2988-2026 · search recall number Z-2988-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.