Device evidence

device-recall:cfres:117164

ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Official recall number

Z-1145-2013

Evidence summary

Product code: DXT
Recall status: Terminated
Event initiated: March 15, 2013
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1145-2013