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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Incisive CT

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 Class 2 Device Recall Philips Incisive CTsee related information
Date Initiated by FirmJune 26, 2026
Date PostedAugust 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2988-2026
Recall Event ID 99511
510(K)NumberK212441 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductPhilips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Code Information Device Identifier: (01)00884838085015, (01)00884838105508.
FEI Number 3009529630
Recalling Firm/
Manufacturer		 Philips Healthcare (Suzhou) Co., Ltd.
Suzhou Industrial Park
No. 258 Zhongyuan Road; Pingjiang
Suzhou China
For Additional Information Contact
512-67336833
Manufacturer Reason
for Recall		Potential of failing to trigger clinical scan during Bolus Tracking.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips notification dated June 26, 2026 will inform customers of the issue via an Electronic Product Radiation Correction notification. Philips will schedule an appointment with customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2026-PD-CTAMI-108.
DistributionU.S. Nationwide and U.S. Territories distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
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