Z-2522-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 8, 2020
- Termination Date
- January 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
uCT 760 System, Computed Tomography X-ray System
Reason for Recall
Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
Distribution Pattern
Distributed to two customers. Both customers located in Houston, Texas.
Code Information
Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.