SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
Lot Codes / Batch Numbers
UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Products Sold
UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku is recalling SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 9/13/24, recall notices were emailed to consignees asking them to do the following: 1) If the problem occurs it is possible to solve this problem by turning off the power of the system and then pushing the reset switch on the Digital radiography unit s control cabinet. 2) Your firm authorized service representative will be contacting to schedule the implementation of the corrective action but if you are not contacted, contact the firm's National Support. 3) Complete and return the response form via email to response to drodriguez@shimadzu-usa.com If you have questions contact the firm's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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