Shimadzu recalls Sonialvision G4 X-ray systems with certain control boards that may delay or cancel exams when switching between fluoroscopy and radiography modes. Affected units have specific serial numbers and UDI-DI codes.
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.
Shimadzu is recalling Sonialvision G4 X-ray systems that may delay or cancel medical exams when switching between fluoroscopy and radiography modes. This could impact patient care timing but does not cause injury.
The software may fail to display images when switching from fluoroscopy to radiography mode, potentially causing delays or cancellations in medical examinations. This does not involve physical harm to users.
Healthcare facilities using Sonialvision G4 X-ray systems with specific serial numbers or UDI-DI codes are affected. Patients undergoing exams with these systems may experience delays.
Check for serial numbers starting with 41C3518D7001, 41C3518E4001, or 41C3536D9001. Also look for UDI-DI codes 04540217064809 or 04540217064816 on the equipment.
Look for serial numbers starting with 41C3518D7001, 41C3518E4001, or 41C3536D9001.
The recall does not involve injury risk; it only potentially delays or cancels exams.
Check the serial numbers or UDI-DI codes to see if your unit is affected. If it is, contact Shimadzu for further instructions.
Yes, the Sonialvision G4 X-ray systems with serial numbers 41C3518D7001, 41C3518E4001, or 41C3536D9001 are affected.
We’ve drafted a message you can send Shimadzu to request your refund or repair — edit it as you like.
Subject: Recall Z-0316-2025 — Shimadzu Shimadzu Hello, I own a Shimadzu that is covered by recall Z-0316-2025 from Shimadzu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
