Use caution Medical device recall · FDA · Published September 25, 2025

Philips Incisive CT Software Issues: Risk of Incorrect Scans and Rescans

Philips Medical Systems recalls Incisive CT software versions 5.1.0.X and 5.1.1.X for Brazil SKD models. Issues may cause incorrect scans, rescans, or missing ECG data. Affected units must be updated by software fix.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0377-2026Medical device Philips Medical Systems ›

Use caution until it’s fixed

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

Take action

Contact the company

Recalling firmPHILIPS MEDICAL SYSTEMS222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips Medical Systems is recalling Incisive CT scanners sold in Brazil with specific software versions due to multiple software issues that could lead to incorrect scans, rescans, or missing ECG data. These problems may cause patients to be rescanned unnecessarily or result in undiagnosable images. Read more at govinfonow.com/recall/51222-philips-incisive-ct-software-issues-risk-of-incorrect-scans-and.

Source Summary by GovInfoNow · govinfonow.com/recall/51222-philips-incisive-ct-software-issues-risk-of-incorrect-scans-and · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0377-2026

Cite this page

“Philips Incisive CT Software Issues: Risk of Incorrect Scans and Rescans.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51222-philips-incisive-ct-software-issues-risk-of-incorrect-scans-and. Based on FDA recall #Z-0377-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0377-2026%22&limit=1).

Philips Medical Systems voluntarily recalled one Incisive CT scanner (Model: Incisive CT for Brazil SKD, REF 728146, Software Versions 5.1.0.X & 5.1.1.X) on Sept. 25, 2025, according to the FDA. The device poses risks including insufficient dose settings, missed ECG data, incorrect patient orientation, and inconsistent image display.

How to tell if you have it

Brand: Philips Medical Systems
Product: Incisive CT for Brazil SKD
REF: 728146
Software Versions: 5.1.0.X & 5.1.1.X
Serial Number: 540000

The hazard

The recall cites six issues, including unintentional gantry movement, insufficient dose settings leading to noisy images, and missing ECG wave files that cause reconstruction failures. Other hazards include incorrect patient orientation resulting in undiagnosable images, inconsistent preview image display, and errors in auto ROI creation that may prevent clinical scans. These software faults create potential safety risks for patients requiring rescans or additional tracker shots.

Context

GovInfoNow's records show Philips Medical Systems has issued four other recalls since Feb. 11, 2022. Recent similar recalls include a June 11, 2026 notice regarding CT scanners needing manual bolus tracking triggers and a March 7, 2026 alert about spectral CT software potentially causing stuck gantries. Other recent recalls of similar products include a Dec. 13, 2023 Philips Spectral CT 7500 recall for misdiagnosis risk (2023-12-13), a June 26, 2026 Incisive CT software failure notice (2026-06-26), a Dec. 3, 2025 unstable sensor alert (2025-12-03), and an Aug. 7, 2026 Ingenuity CT unintended radiation risk recall (2026-08-07).

How to tell if you have this one

Check if your Philips Incisive CT scanner has product code 728146 and software versions 5.1.0.X or 5.1.1.X. This model was sold in Brazil for SKD (Service Kit Delivery) use.

Brand
Philips Medical Systems
Category
Medical device

FDA recall event · 3 products

All 3 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
Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;

Recall number	Product, codes & lots	Quantity
Z-0375-2026	Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;; 1. Product Code (REF): 728143; UDI-DI: 00884838085015; Serial Numbers: 500417, 500404, 500408, 500277, 500037, 500475, 500243, 500028, 500024, 510003, 33022, 500521, 500444, 500305, 500174, 500150, 500029, 500018, 500546, 500472, 510023, 510008, 500532, 500483, 500471, 500446, 500258, 500195, 500568, 33005, 2. Product Code (REF): 728144; UDI-DI: 00884838105508; Serial Numbers: 550375, 550259, 550241, 550195, 550187, 550159, 550116, 550063, 550052, 55400406111940, 550298, 550092, 550188, 5400406113211, 550467, 550328, 550177, 550136, 34318, 550300, 550296, 550248, 550234, 34252, 34224, 34217, 34176, 34157, 34147, 34142, 34108, 550605, 550580, 550129, 550103, 550056, 500509, 34499, 34458, 34405, 34136, 550040, 550447, 550041, 550359, 550350, 34546, 34188, 550686, 550065, 550059, 550025, 500506, 34237, 550474, 550141, 550115, 34401, 552001, 34529, 34408, 34532, 34516, 34280, 34259, 34251, 34223, 34208, 34179, 34174, 34159, 34137, 34082, 34080, 34003;	105 units
Z-0376-2026	Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;; Product Code (REF): 728285; UDI-DI: 00884838113237; Serial Numbers: 800031, 800073, 800070, 35064, 35056, 35043, 35029, 800084, 800083, 800076, 800063, 800058, 800048, 800040, 800039, 800038, 800034, 800033, 800028, 800026, 800021, 800018, 800015, 800011, 800010, 800078, 800071, 35078, 35068, 35048, 35036, 800023, 800008, 800004, 800001, 35073, 35069, 35067, 35058, 35051, 35044, 35034, 35031, 35027, 35019, 35015, 35009, 35001, 800065, 35062, 35042, 35040, 35022, 35016, 35059, 800081, 800062, 800003, 35081, 35065, 35061, 35057, 35053, 35052, 35045, 35041, 35035, 35008, 800005, 35006, 800041, 35080, 800056, 35070, 35033, 35021, 800079, 800077, 800069, 800055, 800054, 800053, 800052, 800007, 800002, 35079, 35071, 35063, 35055, 35046, 35017, 35011, 35007, 35002, 800075, 800045, 800044, 800043, 800029, 800027, 800025, 800024, 800016, 800013, 800009, 800051, 800042, 800061, 800046, 800030, 800019, 800014, 800006, 800074, 800066, 35054, 35018, 800060, 800059, 800072, 35032, 35023, 35003, 800080, 800047, 35039, 35038, 35004, 76001, 35077, 35066, 35060, 35030, 35025, 35013, 35012, 35010, 35037, 35082, 35072, 35005, 35026, 800057, 800067, 800037, 800036, 800032, 800020, 35076, 35075, 35074, 35050, 35049, 35047, 35028, 35024, 35020, 35014, 800050, 800049, 800082, 800064, 800022, 800017, 800012;	165 units
Z-0377-2026	Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;; Product Code (REF): 728146; UDI-DI: None; Serial Number: 540000	1 unit (OUS only)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your scanner's software version by checking the device settings or documentation. If it is 5.1.0.X or 5.1.1.X, it is affected.
Update Software
Contact Philips Medical Systems to obtain the software update that resolves these issues. The update will fix the problems with image quality and scan accuracy.

Where it went and when

Where it was distributed

Distributed in 17 states and Puerto Rico, and outside the U.S.

FDA distribution: “Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 41 days after the firm started it.

Sep 25, 2025Firm started the recall
Oct 27, 2025FDA classified it Class II
Nov 5, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Philips Medical Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/51222-philips-incisive-ct-software-issues-risk-of-incorrect-scans-and">Philips Incisive CT Software Issues: Risk of Incorrect Scans and Rescans (GovInfoNow)</a>

Where this comes from

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-0377-2026 (September 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0377-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.