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 other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

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