Device product
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Z-0448-2021
Product summary
- Event
- Event 86269
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-0448-2021
Official wording
Reason: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Code information: Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
Distribution pattern: US Nationwide distribution including in the state of TX.
Derived failure modes
-
Unknown
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.