Toshiba recalls specific INFX-8000V fluoroscopy systems and INFINIX CF-I/BP Plus Cardiac systems due to ceiling drive bolts loosening during use, potentially causing device errors.
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Toshiba is recalling certain INFX-8000V fluoroscopy X-ray systems and INFINIX CF-I/BP Plus Cardiac systems because fastening bolts in the ceiling drive mechanism can loosen, causing the device to stop working during exams. This could lead to incomplete procedures or safety issues if the system fails unexpectedly.
The fastening bolts in the ceiling drive mechanism can loosen during use, causing the device to stop working unexpectedly. This error may lead to incomplete medical procedures or potential safety issues if the system fails during an exam.
Medical facilities using the recalled systems with specific serial numbers are affected. Patients undergoing exams with these systems may be at risk if the device malfunctions during procedures.
Check for the specific serial numbers listed in the recall: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, and others. These serial numbers are unique to the recalled systems.
Identify if your system has one of the listed serial numbers from the recall notice.
The recall occurs because fastening bolts in the ceiling drive mechanism can loosen during use, causing the device to stop working unexpectedly during exams.
Check your system's serial number against the list provided in the recall notice to determine if it is affected.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Toshiba to request your refund or repair — edit it as you like.
Subject: Recall Z-0844-2018 — Toshiba Toshiba Hello, I own a Toshiba that is covered by recall Z-0844-2018 from Toshiba. 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.
