Shimadzu recalls FluoroSpeed X1 X-ray systems that may exceed radiation dose rates in fluoroscopic mode due to installation issues. Affected units have specific serial numbers listed in the recall notice.
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 is recalling certain X-Ray R/F System FluoroSpeed X1 models because they may exceed safe radiation dose rates during fluoroscopy in specific installation scenarios. This could pose a risk of unnecessary radiation exposure to patients or staff if the system is used without proper adjustments.
The X-ray system may exceed the radiation dose rate specified in federal regulations during fluoroscopic mode if installation criteria are not properly adjusted. This happens due to inadequate settings in specific cases, potentially leading to unnecessary radiation exposure for patients or medical personnel.
Healthcare facilities using the FluoroSpeed X1 X-ray systems with the listed serial numbers are affected. Staff and patients using these systems during fluoroscopic procedures may be at risk of higher-than-expected radiation exposure.
Check if your FluoroSpeed X1 system has a serial number starting with MQ493E1A or MQ493E1B followed by specific digits listed in the recall notice. The system model is X-Ray R/F System Fluorospeed X1 with generator number D150-40.
Verify if your system has a serial number from the list provided in the recall notice (e.g., MQ493E1A1003).
The recall is due to the X-ray system potentially exceeding safe radiation dose rates during fluoroscopic mode in specific installation scenarios, which could lead to unnecessary radiation exposure.
Check if your FluoroSpeed X1 system has a serial number listed in the recall notice (e.g., MQ493E1A1003).
The recall notice does not specify a remedy, so contact Shimadzu Medical Systems directly for guidance on next steps.
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-0867-2022 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0867-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
