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.
FDA Recall Z-0316-2025 · Posted 2024-11-07
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Recalling FirmSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2024-09-06
Product Quantity3
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.
Firm Action
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 [email protected]
If you have questions contact the firm's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
Root Cause
Software change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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