Device evidence

device-recall:cfres:141654

Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).

Official recall number

Z-0703-2016

Evidence summary

Product code: OWB
Recall status: Terminated
Event initiated: November 03, 2015
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0703-2016