FDA Enforcement
Class II
Terminated
728333 Spectral CT 7500 -Computed Tomography X-ray system
Recall: Z-2318-2021
·
Reported August 25, 2021
Enforcement
- Recall Number
- Z-2318-2021
- Event ID
- 88336
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 25, 2021
- Initiation Date
- June 8, 2021
- Classification Date
- August 18, 2021
- Termination Date
- August 10, 2023
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States
Description
728333 Spectral CT 7500 -Computed Tomography X-ray system
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 Info
Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option
Distribution
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Quantity
1 unit