Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Summary
The FDA issued a Class II for Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Cod by Philips Healthcare (Suzhou) Co., Ltd.. Reason: Potential of failing to trigger clinical scan during Bolus Tracking..
Details
Source
Device Recall
External ID
Z-2988-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Lot/Code Info: Device Identifier: (01)00884838085015, (01)00884838105508.
Quantity Affected: N/A
Reason for Recall
Potential of failing to trigger clinical scan during Bolus Tracking.
Distribution
U.S. Nationwide and U.S. Territories distribution.
Type: FDA Mandated
Recall Initiated: 2026-06-26
Company
Suzhou, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Philips Healthcare (Suzhou) Co., Ltd. has 13 FDA actions in our database, including 3 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Healthcare (Suzhou) Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Healthcare (Suzhou) Co., Ltd. have FDA actions?
Philips Healthcare (Suzhou) Co., Ltd. has 13 FDA actions in our database, including 3 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2988-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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