Incisive CT, software version 5.0 recallZ-2520-2023 · Philips Healthcare · initiated Aug 2, 2023
Class II Open, Classified All recalls posted in September 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Philips will inform customers of the issue via an Electronic Product Radiation Defect notification. Philips will schedule an appointment with customers to install the software update.
Recall details
- Recall number
- Z-2520-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 2, 2023
- Posted by the FDA
- Sep 30, 2023
- Recalling firm
- Philips Healthcare
- Quantity
- 140 systems
- Product code
- JAK
- FDA submissions
- K211168, K212441, K180015
- Distribution
- US Nationwide Distribution
Product description
Incisive CT, software version 5.0
Code information (models, lots, serial numbers)
software version 5.0
Other devices under the same FDA submission
1 device cleared under K211168, K212441, K180015 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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