SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina
Summary
The FDA issued a Class II for SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable f by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. 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 R.
Details
Source
Device Recall
External ID
Z-0316-2025
Action Date
2024-11-13
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Quantity Affected: 3
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-06
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION have FDA actions?
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0316-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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