Derived label

Device software or design

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 ;

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software version 5.3. This issue
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Siemens Healthcare Diagnostics Inc