Z-1586-2023Class II

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

Name: Z-1586-2023 Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Creator: Philips North America
Published: 2023-03-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-03-20 / Open, Classified

FDA source

Philips North America began a recall of Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 on 2023-03-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1586-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-20
Posted: 2023-05-12
Recalling firm: Philips North America LLC
Product: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Product code: JAK System, X-Ray, Tomography, Computed
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 root cause: 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: 3 units US ;2 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.
Product codes and lots: UDI-DI:(01)00884838085015(21) + Serial number US Serial Numbers: 33041, 500301, 500252. OUS Serial Numbers: 33040, 500408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1586-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-12
Z-1586-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-12

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)