Device product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Z-1625-2023
Product summary
- Event
- Event 92238
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1625-2023
Official wording
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
Code information: UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078
Distribution pattern: AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
Derived failure modes
-
Unknown
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