The Recall Desk
HighFDA (Devices)·Z-1786-2022·Announced 2022-10-05

Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall where a software calibration error causes incorrect radiation dose measurements. The error may impede clinical decision-making regarding radiation exposure. No illnesses or injuries have been reported, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Micro-X Ltd. is recalling the MICRO-X ROVER MOBILE X-RAY SYSTEM, MODEL MXU-RV19, a mobile radiographic imaging device. A software calibration error affects the Dose Area Product (DAP) meter, which measures radiation dose to patients. The error causes the device to display incorrect DAP values.

The 42 recalled units were distributed in the United States in California, Nevada, New York, Ohio, Texas, and Washington, and internationally in Australia, France, Israel, Japan, and the United Arab Emirates. When the device displays incorrect radiation dose readings due to this software error, it may impede healthcare providers' ability to make proper decisions regarding radiation exposure management for patients.

The recalled product

Product
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Manufacturer
Micro-X Ltd.
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • calibration-error
  • radiation-dose-measurement-error
  • software-error

Distribution

Distributed nationwide across the United States.

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