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Recall Observatory FDA recall evidence

Device product

Merge LIS

Z-0289-2021

January 23, 2017

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 86449
Status
Terminated
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-0289-2021

Official wording

Reason: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.

Code information: Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2

Distribution pattern: Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    defect in the software