FDA Device recall Z-2318-2021
728333 Spectral CT 7500 -Computed Tomography X-ray system
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of 728333 Spectral CT 7500 -Computed Tomography X-ray system 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-2318-2021 |
| 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
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.
Identifiers
| code_info | Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 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-2318-2021%22
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