Derived label

Device software or design

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: design issue
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Merit Medical Systems, Inc.