Toshiba recalls specific INFX-8000C fluoroscopy systems due to ceiling drive bolts loosening during use, potentially causing device errors. Affected units have listed 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-8000C fluoroscopy X-ray systems because fastening bolts in the ceiling drive mechanism can loosen, causing device errors during examinations. This could lead to improper operation of the system.
The fastening bolts in the ceiling drive mechanism can loosen during use, causing the device to disable the ceiling drive operation. This error may lead to improper X-ray imaging or system malfunctions during examinations.
Medical facilities using the recalled INFX-8000C systems are most at risk. Patients undergoing X-ray procedures with these systems may be affected.
Check for serial numbers listed in the recall: U6A1472001, UWB1422001, U6C13Y2007, A3A14Z2001, A6B1532003, A1B1552001, A6B1582004, A9B1622002, A9A1592001, A5C1622001, A6B1682005, A6B16X2006, A5C16Y2002, A1D1752002, AFA1662001, A9B1722003, A6B1742007, A6A1492002, A4B1472002.
Look for the listed serial numbers on the device to confirm if it is affected.
The fastening bolts in the ceiling drive mechanism can loosen during use, causing the device to disable the ceiling drive operation and potentially leading to errors during examinations.
Check the device for the listed serial numbers to see if it is affected. If it is, contact Toshiba American Medical Systems for further instructions.
The recall record does not specify a remedy or fix.
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-0843-2018 — Toshiba American Medical Systems Toshiba American Medical Systems Hello, I own a Toshiba American Medical Systems that is covered by recall Z-0843-2018 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.