FDA Device recall Z-1625-2023
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
- FDA Device
- Class II
- ongoing
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS) by Philips Headquarters Cambridge, citing potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1625-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-12 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Headquarters Cambridge |
| Distribution | AR, CA, OK, TX |
Product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Reason
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Identifiers
| code_info | UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078 |
|---|
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-1625-2023%22
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