Device evidence

device-recall:cfres:120124

MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.

Official recall number

Z-1874-2013

Evidence summary

Product code: FRN
Recall status: Terminated
Event initiated: July 01, 2013
Root cause: Software Manufacturing/Software Deployment
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1874-2013