Shimadzu Medical Systems recalls X-Ray TV System SonialVision Safire17 models due to potential radiation dose exceeding safety limits in fluoroscopic mode. Affected units have specific serial numbers.
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 Safire17 models because radiation levels may exceed safe limits during fluoroscopy. This could lead to unnecessary radiation exposure for patients or staff if the device is used without proper adjustments.
The X-ray system may emit radiation levels higher than allowed by safety standards during fluoroscopic imaging if installation settings are not adjusted correctly. This happens because the device lacks sufficient criteria to ensure safe radiation levels in specific usage scenarios.
Healthcare facilities using the SonialVision Safire17 X-ray system are affected. Patients and medical staff are at risk if the device is used without proper adjustments.
Check for the model name 'SonialVision safire17' and serial numbers starting with 3M5249D followed by specific digits listed in the recall notice.
Look for serial numbers starting with 3M5249D followed by specific digits listed in the recall notice.
The X-ray system may emit radiation levels exceeding safety limits during fluoroscopic mode if installation settings are not adjusted correctly.
Check for the model name 'SonialVision safire17' and serial numbers starting with 3M5249D followed by specific digits listed in the recall notice.
The recall record does not specify a remedy or fix for this issue.
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-0869-2022 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0869-2022 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.
