Skip to content
Recall Observatory FDA recall evidence

Derived label

Device software or design

Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software. Error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Braemar Manufacturing, LLC

Field note

Send feedback

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