Device product

728333 Spectral CT 7500 -Computed Tomography X-ray system

Z-2318-2021

June 08, 2021

Class II

Product summary

Firm: Philips North America Llc
Event: Event 88336
Status: Terminated
Classification: Class II
Quantity: 1 unit
Official record key: device-enforcement:Z-2318-2021

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/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 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