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Recall Observatory FDA recall evidence

Device product

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Z-1392-2025

February 10, 2025

Class II

Product summary

Firm
Brainlab AG
Event
Event 96241
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1392-2025

Official wording

Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

Code information: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.