Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SYSTEM, XRAY, TOMOGRAPHY, COMPUTED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall SYSTEM, XRAY, TOMOGRAPHY, COMPUTEDsee related information
Date Initiated by FirmDecember 03, 2025
Date PostedJanuary 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1003-2026
Recall Event ID 98238
510(K)NumberK180015 K212441 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductPhilips Incisive CT
Code Information N/A
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 for incomplete scan due to unstable connection inside of floating sensor.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install a hardware solution that will change the method of connection for the rear handle floating sensor. 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: 2025-PD-CTAMI-109 or FCO72800843.
Quantity in Commerce35
DistributionU.S. and U.S. territories
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
-
-