Device evidence

device-recall:cfres:169658

AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

Official recall number

Z-0849-2019

Evidence summary

Product code: FKX
Recall status: Terminated
Event initiated: December 11, 2018
Root cause: Software design
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0849-2019