Device product
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Z-2261-2023
Product summary
- Event
- Event 92202
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units OUS
- Official record key
device-enforcement:Z-2261-2023
Official wording
Reason: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Code information: UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430
Distribution pattern: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
Derived failure modes
-
Unknown
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down