Device evidence

device-recall:cfres:163437

Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

Official recall number

Z-1607-2018

Evidence summary

Product code: KPR
Recall status: Terminated
Event initiated: March 26, 2018
Root cause: Nonconforming Material/Component
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1607-2018