Philips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
Philips is recalling Incisive CT scanners with specific software versions due to a potential failure to trigger clinical scans during bolus tracking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (failure to trigger a clinical scan) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Healthcare (Suzhou) Co., Ltd. is recalling Philips Incisive CT scanners equipped with software versions V4.5 and V5.0. The affected devices are identified by Product Codes 728143 and 728144, with Device Identifiers (01)00884838085015 and (01)00884838105508. The recall covers units distributed nationwide in the United States and U.S. territories.
The recall is issued because of a potential failure to trigger a clinical scan during the bolus tracking process. This defect could prevent the scanner from initiating the imaging sequence at the correct time during a contrast-enhanced study.
Healthcare facilities and consumers should contact Philips Healthcare for further instructions on how to address this issue. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- Category
- Medical Device — CT Scanner
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Device Identifier: (01)00884838085015
- (01)00884838105508.
Distribution
Distributed nationwide across the United States.
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