FUJIFILM recalls specific FDR Visionary Suite models for potential tube rupture causing patient injury during skull or spine imaging. Affected units have unique serial numbers and model numbers listed in the recall notice.
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FUJIFILM is recalling certain FDR Visionary Suite medical imaging devices that could have bolts failing under stress, potentially causing the tube support to fall and injure patients during skull or spine imaging. This recall is important because the failure could lead to serious harm if the device malfunctions during use.
The bolts on the CH-200 tube may fatigue and rupture over time, causing the tube support to fall. This could happen during normal use when the device is operating, potentially injuring patients.
Healthcare facilities using the recalled FDR Visionary Suite models for radiography exams of the skull, spinal column, or other body parts are affected. Patients undergoing these exams with the faulty equipment are at risk of injury.
Check for the model numbers 566-16130-23 or 566-16130-33 and serial numbers listed in the recall notice. The device is used for generating digital or conventional radiographic images of the skull, spinal column, chest, abdomen, or extremities.
Immediately stop using the device if it has the model numbers or serial numbers listed in the recall notice.
The bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall and potentially injure patients during imaging.
The affected models have the model numbers 566-16130-23 or 566-16130-33 and specific serial numbers listed in the recall notice.
Check the model numbers and serial numbers on your device against the list provided in the recall notice.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1898-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1898-2024 from FUJIFILM Healthcare. 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.
