FDA (Devices) recall action 79153
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling operation.
Toshiba is recalling two INFX-8000H Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Toshiba is recalling 17 INFX-8000F Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.