Use cautionMedical device recall · FDA · Published April 25, 2023
Philips Incisive CT X-Ray System Model 728146 Recall: Metal Box May Detach and Cause
Philips recalls Incisive CT X-Ray System Model 728146 due to risk of metal mounting box detaching and causing injury or system shutdown. Affected units have specific serial numbers.
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Take action
Contact the company
📍Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296
“Philips Incisive CT X-Ray System Model 728146 Recall: Metal Box May Detach and Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58501-philips-incisive-ct-x-ray-system-model-728146-recall-metal. Based on FDA recall #Z-2259-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2259-2023%22&limit=1).
Philips North America voluntarily recalled the Incisive CT for Brazil SKD-Computed Tomography X-Ray System (Model 728146) on April 25, 2023, according to the FDA. The device may cause injury if its metal mounting box becomes expelled.
How to tell if you have it
Brand: Philips
Product: Incisive CT for Brazil SKD-Computed Tomography X-Ray System
The metal mounting box on the rotating scanner's rotor may become expelled and contact other components, potentially causing injury to a user. If detached, the system emits a loud noise and shuts down.
Context
GovInfoNow's records show Philips North America has issued 30 other recalls since December 24, 2020. Recent recalls include the Evolution upgrade 1.5T and 3.0T on August 28, 2026, and the Patient Information Center iX Software on July 31, 2026. Other recent recalls of similar products include the Philips IQon Spectral CT Recall (January 7, 2026), the Philips Spectral CT Recall (January 7, 2026), and the Philips Brilliance iCT CT Scanner Recall (January 7, 2026).
How to tell if you have this one
Check if your unit has the model number 728146 and serial numbers listed: 540000-540018. This recall applies to units sold in Brazil.
Brand
Philips
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149; UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430
6 units OUS
Based on the official FDA remedy
What to do — step by step
Check for Detachment
Look for a loud noise and system shutdown if the metal mounting box detaches.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2259-2023 (April 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2259-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.