FDA Device recall Z-2520-2023
Incisive CT, software version 5.0
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Incisive CT, software version 5.0 by Philips Healthcare, citing 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 opt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2520-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-02 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Incisive CT, software version 5.0
Reason
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.
Identifiers
| code_info | software version 5.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2023%22
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