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U.S. Department of Health and Human Services

Class 2 Device Recall Incisive CT

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  Class 2 Device Recall Incisive CT see related information
Date Initiated by Firm March 20, 2023
Date Posted May 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1585-2023
Recall Event ID 92117
510(K)Number K212441  K180015  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Incisive CT -Computed Tomography X-Ray System
Model Number: 72814
Code Information UDI-DI: (01)00884838105508(21) + Serial number US Serial Numbers: 550243, 34111, 34092, 34066, 34064, 34047, 34042, 34025, 34031, 34033 OUS Serial Numbers: System Serial Number 550263 550249 550239 550215 550211 550091 550188 550187 550186 550174 550172 552041 550164 34107 550140 34062 550099 550082 550071 550068 550059 34020 550038 550040 550021 550036 550018 550014 550011 550010 550009 550008 550007 550240 550126 550241
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact Philips Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall		 Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips Medical issued Urgent Medical Device Correction Letter Multi-Function Switch Unload Pedal Foot Entrapment on 3/20/23 to US consignees via Certified United States Postal Service (USPS) with delivery confirmation. International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. " Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware lnterventional Controls to fulfill the normal patient unloading function, as instructed in the IFU. " You may continue to use Load Pedal, and Free-Float Pedal of Foot Switch, as they are not affected by this Urgent Medical Device Correction Letter. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the solution to resolve this issue (refer to FCO72800794). If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce 10 units US; 36 units OUS
Distribution Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, Republic Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten (Dutch part), South Africa, Thailand, United Kingdom, Utd. Arab. Emir.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAK and Original Applicant = Philips Healthcare (Suzhou) Co., Ltd.
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