Incisive CT recallZ-1585-2023 · Philips North America · initiated Mar 20, 2023

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

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number

Z-1585-2023

Status

Open, Classified

Initiated by the company

Mar 20, 2023

Posted by the FDA

May 12, 2023

Recalling firm

Philips North America

Quantity

10 units US; 36 units OUS

Product code

JAK

FDA submissions

K212441, K180015

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.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Incisive CT

  Philips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed
  9 recalls20 reports

Product lines

• Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2 models · 25 reports · 16 recalls

Other devices under the same FDA submission

1 device cleared under K212441, K180015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Incisive CT

  Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed
  13 recalls5 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92117).

• Z-1586-2023 · Open, Classified
  Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813