CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report

Philips Incisive CT recalled by Philips Healthcare (Suzhou) Co

Philips Healthcare (Suzhou) Co is recalling Philips Incisive CT. The recall was initiated on 3 Dec 2025 and the FDA has classified it as Class II.

Recall details

Recall number: Z-1003-2026
FDA event ID: 98238
Recalling firm: Philips Healthcare (Suzhou) Co, Suzhou
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2025
FDA classified: 8 Jan 2026
Reported: 14 Jan 2026
Type: FDA Mandated
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Dec 2025	Recall initiated by company
8 Jan 2026	Classified by FDA	+36 days
14 Jan 2026	Published in enforcement report	+6 days

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

Reason for recall

Potential for incomplete scan due to unstable connection inside of floating sensor.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips Incisive CT

Where it was distributed

U.S. and U.S. territories

Questions about this recall

Is Philips Incisive CT recalled?

Yes. Philips Healthcare (Suzhou) Co recalled Philips Incisive CT on 3 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1003-2026.

Why was it recalled?

Potential for incomplete scan due to unstable connection inside of floating sensor.

Where was it sold?

U.S. and U.S. territories

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.

More recalls from Philips Healthcare (Suzhou) Co

All 4

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Philips Incisive CT recalled by Philips Healthcare (Suzhou) Co	Philips Healthcare (Suzhou) Co	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Incisive CT recalled by Philips Healthcare (Suzhou) Co	Philips Healthcare (Suzhou) Co	Lead & Heavy Metals	Nationwide
24 Mar 2021Device	CLASS II	Philips CT systems are advanced continuous-rotation recalled	Philips Healthcare (Suzhou) Co	Device Malfunction	Nationwide

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