Device evidence

device-recall:cfres:124744

Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Official recall number

Z-0804-2014

Evidence summary

Product code: JAA
Recall status: Terminated
Event initiated: November 08, 2013
Root cause: Employee error
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0804-2014