HIGH

MEDITECH Expands Recall of Clinical Calculator Over Data Loss Risk

MEDITECH recalled 148 units of its clinical calculator module on February 5, 2025 due to a malfunction that may result in data loss. Users may experience issues when entering multiple keys, causing data removal from the first field of screens or questionnaires. Medical Information Technology advises immediate cessation of use.

Hazard Information

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

What You Should Do

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

Product Details

The recall involves MEDITECH Expanse Laboratory software versions 2.1 and 2.2. The units were distributed worldwide, including the US, British Virgin Islands, Canada, Ireland, and the United Kingdom.

The Hazard

The device may remove data from the first field of screens when users enter multiple keys simultaneously. This error could lead to incomplete or inaccurate patient data.

Reported Incidents

No specific incidents or injuries related to this malfunction have been reported. However, the risk remains high due to potential inaccuracies in clinical data.

What to Do

Patients and healthcare providers should discontinue use immediately. Follow the recall instructions provided by MEDITECH and contact Medical Information Technology for further guidance.

Contact Information

For more information, contact Medical Information Technology, Inc. via email. Visit the FDA recall page for more details.

Key Facts

  • 148 units recalled
  • Software versions: 2.1, 2.2
  • Distributed worldwide
  • Stop use immediately advised
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCalculator/Data Processing Module
Sold At
Multiple Retailers

Product Details

Model Numbers
Software Release: 2.1
2.2 (using the Web Presentation Layer)
UDI: 00863529000155.
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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