[Recalled] Incisive CT, software version 5.0 — Philips has identified three software issues with compliance concerns to Subcha… | FDA 2023-08-02
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Incisive CT, software version 5.0 |
|---|---|
| Brand / manufacturer | Philips Healthcare |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2520-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 02 August 2023 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.