FDA Enforcement
Class II
Terminated
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Recall: Z-2315-2021
·
Reported August 25, 2021
Enforcement
- Recall Number
- Z-2315-2021
- 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
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-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
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
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Quantity
2 units