Lower risk Medical device recall · FDA · Published December 23, 2022

Philips Incisive CT Software 5.0.0 Recall: Misdiagnosis Risk from Image Artifacts

Philips Healthcare recalls Incisive CT models 728143 & 728144 with software version 5.0.0 due to potential misdiagnosis from image artifacts and incorrect labels. Affected units may require rescan or correction.

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

🇺🇸 FDA recall #Z-0640-2024Medical device Philips Healthcare ›

Lower-risk recall

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operator s voice are too quiet, patient can t hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

Take action

Contact the company

Recalling firmPhilips Healthcare (Suzhou) Co., Ltd.Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang · Suzhou, China

✎ GovInfoNow plain-language explainer

Philips Healthcare is recalling two specific CT scanner models with software version 5.0.0 because software issues could cause misdiagnosis through image artifacts or incorrect labels. This affects medical imaging accuracy and may require additional scans. Read more at govinfonow.com/recall/59054-philips-incisive-ct-software-5-0-0-recall-misdiagnosis-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59054-philips-incisive-ct-software-5-0-0-recall-misdiagnosis-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0640-2024

Cite this page

“Philips Incisive CT Software 5.0.0 Recall: Misdiagnosis Risk from Image Artifacts.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59054-philips-incisive-ct-software-5-0-0-recall-misdiagnosis-risk. Based on FDA recall #Z-0640-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0640-2024%22&limit=1).

The FDA announced on 2022-12-23 that Philips Healthcare (Suzhou) Co., Ltd. is recalling Incisive CT units, models 728143 and 728144 running Software Version 5.0.0. The agency cited multiple software issues that could lead to misdiagnosis due to image artifacts or incorrect orientation labels.

How to tell if you have it

Philips Healthcare Incisive CT, models 728143 and 728144
Software Version 5.0.0
UDI-DI: 00884838085015 (Model 728143)
UDI-DI: 00884838105508 (Model 728144)

The hazard

According to the FDA, the recall addresses software issues that may cause image artifacts, reversed orientation labels in 2D images, or the need for a CT rescan. Other reported defects include non-functional auto voice during cardiac scans, quiet audio levels, incomplete image reconstruction, and couch motion signal errors.

Context

GovInfoNow's records show Philips Healthcare (Suzhou) Co., Ltd. has issued three other recalls since 2021-02-24. Recent similar recalls include the 2026-06-26 Philips Incisive CT Software V4.5/V5.0 Recall for potential bolus tracking failure, the 2025-12-03 Philips Incisive Recall regarding unstable sensors causing incomplete scans, and the 2021-02-24 Philips CT Systems Recall where the couch may fail to lock. Other recent recalls of similar products include the 2026-08-07 Philips Ingenuity CT Scanners recall for unintended radiation risk, the 2026-08-07 Philips Brilliance CT Scanners recall for unintended radiation risk in Software 4.1.10.x, and the 2026-08-07 Philips IQon Spectral CT Software 4.7.7.x Recall for unintended radiation risk.

How to tell if you have this one

Check if your Philips Incisive CT scanner has model numbers 728143 or 728144 and software version 5.0.0. The unique device identifiers (UDI-DI) are 00884838085015 for model 728143 and 00884838105508 for model 728144.

Brand
Philips Healthcare
Category
Medical device

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 version 5.0.0, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 36 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Wisconsin.

Recall timeline

FDA published this recall 13 months after the firm started it.

Dec 23, 2022Firm started the recall
Jan 5, 2024FDA classified it Class II
Jan 17, 2024Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any immediate safety risks?

No immediate physical risks are reported; the issue relates to potential misdiagnosis, not direct harm to users.

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Link to this recall

<a href="https://govinfonow.com/recall/59054-philips-incisive-ct-software-5-0-0-recall-misdiagnosis-risk">Philips Incisive CT Software 5.0.0 Recall: Misdiagnosis Risk from Image Artifacts (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-0640-2024 (December 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0640-2024 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.