Recall- Software Collaboration Issue Displaying Incorrect Values

Company: Micro-X Ltd.
Date of Enforcement Report: 9/23/2022
ClassII

PRODUCT

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Recall Number:

Z-1786-2022

REASON

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

RECALLING FIRM/MANUFACTURER

Micro-X Ltd.

VOLUME OF PRODUCT IN COMMERCE

42 units

DISTRIBUTION

Worldwide distribution – U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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