CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report

Philips Incisive CT -Computed Tomography X-Ray System recalled

Philips North America is recalling Philips Incisive CT -Computed Tomography X-Ray System, distributed nationwide in the US. The recall was initiated on 20 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI:(01)00884838085015(21) + Serial number US Serial Numbers: 33041, 500301, 500252. OUS Serial Numbers: 33040, 500408

Quantity recalled3 units US ;2 units OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1586-2023
FDA event ID: 92117
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2023
FDA classified: 12 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

20 Mar 2023	Recall initiated by company
12 May 2023	Classified by FDA	+53 days
24 May 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arkansas California Florida Illinois Indiana Michigan Missouri New York Tennessee Texas Vermont

Questions about this recall

Is Philips Incisive CT -Computed Tomography X-Ray System recalled?

Yes. Philips North America recalled Philips Incisive CT -Computed Tomography X-Ray System on 20 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1586-2023.

Why was it 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

Which lots are affected?

UDI-DI:(01)00884838085015(21) + Serial number US Serial Numbers: 33041, 500301, 500252. OUS Serial Numbers: 33040, 500408

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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