MEDITECH released an active recall for the Expanse Laboratory calculator/data processing module. The recall covers 148 units distributed worldwide, including the US, UK, Canada, Ireland and the British Virgin Islands. The hazard concerns simultaneous multi-key inputs potentially removing data from the first field in screens or questionnaires.
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medical Information Technology, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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MEDITECH Expanse is a hospital information system platform. The calculator/data processing module helps clinicians process inputs and generate results across laboratories and pathology departments.
If multiple keys trigger input at once, the system may remove data from the first field, risking data integrity in screens with multiple fields.
This recall is not described as part of a broader industry pattern.
High risk to data integrity in clinical workflows. Affects patient data accuracy and could delay results.
Refer to MEDITECH recall instructions and FDA page Z-2569-2025.
Remediation timelines vary; follow manufacturer guidance. Expect weeks for instructions and potential software update.
Document device model, software version, UDI, dates of recall notification, and communications with MEDITECH. Store correspondence and screenshots.
Product: MEDITECH Expanse Laboratory calculator/data processing module for clinical use. Models include Software Release 2.1 and 2.2 (Web Presentation Layer). UDI: 00863529000155. Quantity: 148 units. Distribution: Worldwide (US nationwide; Britain, Canada, Ireland, United Kingdom). Recall date: 2025-02-05. Status: ACTIVE.
No injuries or incidents are reported in the provided data.
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