Device evidence

device-recall:cfres:121520

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

Official recall number

Z-0197-2014

Evidence summary

Product code: FRN
Recall status: Terminated
Event initiated: June 10, 2013
Root cause: Process design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0197-2014