Device product
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Z-0522-2018
Product summary
- Event
- Event 79004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0522-2018
Official wording
Reason: One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Code information: Ingenuity TF PET/CT Model # 882442
Distribution pattern: One domestic and 1 foreign consignee ( Spain)
Derived failure modes
-
Unknown
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.