Philips Healthcare recalls Incisive CT software version 5.0 due to potential scan inaccuracies that could affect medical imaging results. Affected units may require software updates to ensure proper scan planning and safety.
Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.
Take action
Contact the company
📍Recalling firmPhilips Healthcare222 Jacobs St · Cambridge, MA 02141-2289
✎ GovInfoNow plain-language explainer
Philips Healthcare is recalling Incisive CT software version 5.0 because it has three issues that could cause scans to be misaligned or not start at the right time. This might lead to incorrect medical imaging results, which could affect patient care. Read more at govinfonow.com/recall/57551-philips-incisive-ct-software-5-0-recall-scan-accuracy-risks.
“Philips Incisive CT Software 5.0 Recall: Scan Accuracy Risks.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57551-philips-incisive-ct-software-5-0-recall-scan-accuracy-risks. Based on FDA recall #Z-2520-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2023%22&limit=1).
The FDA announced on 2023-08-02 that Philips Healthcare is recalling Incisive CT systems with software version 5.0 due to compliance concerns regarding scan timing and area deviations. The agency identified three specific software issues affecting the operation of the 140 distributed units.
How to tell if you have it
Brand: Philips Healthcare
Product: Incisive CT, software version 5.0
Quantity: 140 systems
The hazard
The recall addresses three software issues where coronary CTA scans may not trigger at the optimal time, aborted surviews for scan planning result in deviations from the intended area, and clinical scans with bariatric couches deviate if the surview length exceeds 1832mm.
Context
GovInfoNow's records show Philips Healthcare has 6 other recalls on record since 2018-06-11. Other recent recalls of similar products include Philips StentBoost Live R2.0 (2022-02-02), Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software (2021-09-24), and Philips CombiDiagnost R90 (2021-09-22). Additional recent recalls include Philips Incisive CT Software V4.5/V5.0 (2026-06-26), Philips Incisive CT (2025-12-03), and Philips Ingenuity CT Scanners (2026-08-07).
How to tell if you have this one
Check if your Philips Incisive CT system has software version 5.0. The recall applies to this specific software version, not the hardware.
Brand
Philips Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Incisive CT software version to see if it is 5.0.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 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-2520-2023 (August 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2520-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.