Device evidence

device-recall:cfres:208053

Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;

Official recall number

Z-2214-2024

Evidence summary

Product code: CHL
Recall status: Open, Classified
Event initiated: May 17, 2024
Root cause: Software Design Change
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2214-2024