Philips Incisive CT with software V4.5&V5.0 recall (Philips Healthcare (Suzhou) Co., Ltd.)
Medical deviceClass IIOngoing
Summary: Philips Healthcare (Suzhou) Co., Ltd. is recalling 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.
What is being recalled
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Why
Potential of failing to trigger clinical scan during Bolus Tracking.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide and U.S. Territories distribution.
How to tell if yours is affected
Device Identifier: (01)00884838085015, (01)00884838105508.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2988-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 26, 2026 |
| Reported | September 2, 2026 |
| Company | Philips Healthcare (Suzhou) Co., Ltd. |
| Company location | Suzhou, N/A, China |
| Initiated by | FDA Mandated |
| Quantity | N/A |
More recalls from Philips Healthcare (Suzhou) Co., Ltd. · all medical device recalls · recalls from June 2026