FDA Device recall Z-2314-2021
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades by Philips North America, citing when setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2314-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-08 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2314-2021%22
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