Shimadzu Medical Systems recalls X-Ray TV System SonialVision G4 models with potential radiation dose exceeding safety limits in fluoroscopic mode. Affected units have specific serial numbers listed. Consumers should contact Shimadzu for details.
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
Shimadzu Medical Systems is recalling X-Ray TV System SonialVision G4 models due to a risk that radiation dose may exceed safety limits during fluoroscopic mode use. This could lead to unnecessary radiation exposure for patients or staff if the device is not properly adjusted.
The system may emit radiation levels exceeding safety limits in fluoroscopic mode due to inadequate adjusting criteria during installation. This could result in higher than intended radiation doses for patients or medical personnel during certain procedures.
Healthcare facilities using the SonialVision G4 X-ray TV system are most at risk, particularly those with specific serial numbers listed in the recall. Patients and medical staff exposed during improper use may face unnecessary radiation exposure.
Check if your X-Ray TV System SonialVision G4 has a serial number starting with '41C351' followed by 10 digits. The affected models include specific serial numbers listed in the recall notice.
Reach out to Shimadzu Medical Systems for specific guidance on your unit and whether it is affected.
The recall is due to a potential risk that radiation dose may exceed safety limits in fluoroscopic mode because of inadequate adjusting criteria during installation.
Check if your X-Ray TV System SonialVision G4 has a serial number starting with '41C351' followed by 10 digits. The affected models include specific serial numbers listed in the recall notice.
Contact Shimadzu Medical Systems for specific guidance on your unit and whether it is affected.
We’ve drafted a message you can send Shimadzu Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0868-2022 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0868-2022 from Shimadzu Medical Systems. 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.
