Device Recall INFX8000C Fluoroscopic XRay Systems 의 리콜

Recall

79153

Class 2

Z-0843-2018

2017-12-29

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161842

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.

A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.