Z-2314-2021 Class II Terminated
FDA device recall Z-2314-2021 was initiated by Philips North America Llc on June 8, 2021 and is designated Class II. Reason for recall: 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 recomme… The recall status is terminated (terminated August 10, 2023). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- June 8, 2021
- Termination Date
- August 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Code Information
S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option