—#199720

Product

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K180015, K212441
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-03-20
Posted by FDA: 2023-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.