Skip to content
Recall Observatory FDA recall evidence

Device product

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

Z-2569-2025

February 05, 2025

Class II

Product summary

Firm
Medical Information Technology, Inc.
Event
Event 97455
Status
Ongoing
Classification
Class II
Quantity
148 units
Official record key
device-enforcement:Z-2569-2025

Official wording

Reason: Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

Code information: Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.