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FDA device recall Z-2569-2025 · posted 2025-09-16 · Open, Classified

Recall details

Recalling firm
Medical Information Technology, Inc.
Reason for recall
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Action taken
Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
Root cause
Software design
Status
Open, Classified
Product code
JQP
Quantity affected
148 units
Distribution
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
Date initiated
2025-02-05
Date posted
2025-09-16
Location
Canton, MA

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