FDA Device recall Z-0640-2024
Incisive CT, model 728143 & 728144 running Software Version 5.0.0
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Incisive CT, model 728143 & 728144 running Software Version 5.0.0 by Philips Healthcare Suzhou, citing 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:….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0640-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-23 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Healthcare Suzhou |
| Distribution | US |
Product
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Reason
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 operators voice are too quiet, patient cant 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.
Identifiers
| code_info | UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0640-2024%22
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