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.
Reported: November 13, 2024 Initiated: September 6, 2024 #Z-0316-2025
Product Description
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 for Recall
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.
Details
- Recalling Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Units Affected
- 3
- Distribution
- US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
- Location
- Kyoto, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. Units affected: 3.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0316-2025.
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