United StatesPhilips Incisive CT systems running software V4.5 and V5.0 (Product Codes 728143 and 728144; Device Identifiers (01)00884838085015 and (01)00884838105508) distributed in the U.S. and U.S. Territories are affected. They were recalled because the device may fail to trigger a clinical scan during Bolus Tracking.
What's being recalled
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Recalling firm: Philips Healthcare (Suzhou) Co., Ltd., Suzhou, N/A, China.
How to identify it
Device Identifier: (01)00884838085015, (01)00884838105508.
The hazard
Potential of failing to trigger clinical scan during Bolus Tracking.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide and U.S. Territories distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)