Device product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Z-2316-2021
Product summary
- Event
- Event 88336
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2316-2021
Official wording
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Code information: Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option
Distribution pattern: US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Derived failure modes
-
Device software or design
software will result in