FDA Medical devices recall ·
SONIALVISION G4 is a multi-purpose X-ray R/F system recall
- Recall number
- Z-0316-2025
- Date
- (initiated September 6, 2024)
- Company / brand
- Shimadzu Corporation Medical Systems Division
Nishinokyo Kuwabara -Cho, Kyoto, N/A, Japan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
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.
States: Arkansas California Colorado Connecticut Florida Hawaii Iowa Illinois Louisiana Massachusetts Maryland Minnesota Montana North Carolina Nebraska New York Ohio Tennessee Texas Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0316-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.