Device product
uCT 530 Computed Tomography X-Ray System
Z-2472-2020
Product summary
- Event
- Event 85809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2472-2020
Official wording
Reason: Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
Code information: Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
Distribution pattern: Distributed to Texas.
Derived failure modes
-
Unknown
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.