Device product

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Z-2315-2021

June 08, 2021

Class II

Product summary

Firm: Philips North America Llc
Event: Event 88336
Status: Terminated
Classification: Class II
Quantity: 2 units
Official record key: device-enforcement:Z-2315-2021

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: Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 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
reason.device_software_design · v1.0.0

software will result in