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Recall Observatory FDA recall evidence

Device product

MEDITECH Microbiology - Calculator/data processing module, for clinical use.

Z-1124-2014

January 17, 2014

Class II

Product summary

Firm
Medical Information Technology, Inc.
Event
Event 67458
Status
Terminated
Classification
Class II
Quantity
737
Official record key
device-enforcement:Z-1124-2014

Official wording

Reason: Potential for patient results being removed from LAB/EMR.

Code information: Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.

Distribution pattern: Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for patient results being removed from LAB/EMR.