Philips Healthcare recall: Philips Incisive CT with software V4.5&V5.0
Philips Healthcare (Suzhou) Co., Ltd. is recalling Philips Incisive CT with software V4.5&V5.0 – N/A. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on June 26, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Philips Incisive CT with software V4.5&V5.0 |
| Brand | Philips Healthcare |
| Company | Philips Healthcare (Suzhou) Co., Ltd. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 26, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | N/A |
| Recall ID | 99511 |
Recalled products
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- FDA recall number
- Z-2988-2026
- Codes, lots and dates
- Device Identifier: (01)00884838085015, (01)00884838105508.
- Quantity
- N/A
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99511
- Initiated
- FDA Mandated
- Status
- Ongoing
- Firm location
- Suzhou, N/A, China
Why it was recalled
The reason the FDA lists: “Potential of failing to trigger clinical scan during Bolus Tracking.”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide and U.S. Territories distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99511, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Philips Healthcare Philips Incisive CT with software V4.5&V5.0 recalled?
Yes. Philips Healthcare (Suzhou) Co., Ltd. recalled it on June 26, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Potential of failing to trigger clinical scan during Bolus Tracking.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.