Device product
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Z-2705-2020
Product summary
- Event
- Event 85868
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2705-2020
Official wording
Reason: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Code information: SN 353020, 353021, 353023
Distribution pattern: US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Derived failure modes
-
Unknown
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.