Skip to content
Recall Observatory FDA recall evidence

Derived label

Device software or design

TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Abbott Laboratories Inc. (St Jude Medical)

Field note

Send feedback

We'll only use this to respond to your feedback.