FDA Device recall Z-0316-2025
SONIALVISION G4 is a multi-purpose X-ray R/F system
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of SONIALVISION G4 is a multi-purpose X-ray R/F system by Shimadzu Medical Systems Division, citing X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0316-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-06 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Shimadzu Medical Systems Division |
| Distribution | US |
Product
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Reason
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
Identifiers
| code_info | UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0316-2025%22
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