Toshiba recalls INFX-8000H fluoroscopy systems with loose ceiling drive bolts that may disable device operation during exams. Affected units have specific serial numbers.
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 recalls certain INFX-8000H fluoroscopy X-ray systems because loose bolts in the ceiling drive mechanism could disable the device during medical exams. This poses a risk of incorrect imaging or failed procedures if the system malfunctions.
Loose fastening bolts in the ceiling drive mechanism can cause the device to stop working during medical examinations. This may lead to incorrect imaging results or failed procedures if the system becomes inoperable.
Medical facilities using the recalled INFX-8000H systems are most at risk. Patients undergoing exams with these systems could experience incomplete procedures if the device malfunctions.
Check for serial numbers A5B1672001 or AFA1692002 on the INFX-8000H fluoroscopy systems. These units were sold by Toshiba American Medical Systems.
Verify if the ceiling drive operation is disabled during exams by testing the system's functionality.
Loose fastening bolts in the ceiling drive mechanism can cause the device to stop working during medical examinations.
Serial numbers A5B1672001 and AFA1692002.
The recall does not require immediate stoppage; medical facilities should check if the ceiling drive operation is disabled during exams.
We’ve drafted a message you can send Toshiba American Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0845-2018 — Toshiba American Medical Systems Toshiba American Medical Systems Hello, I own a Toshiba American Medical Systems that is covered by recall Z-0845-2018 from Toshiba American 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.
