Device product
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Z-1623-2023
Product summary
- Event
- Event 92238
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-1623-2023
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)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378
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