FDA recall record · openFDA

Micro-X Ltd.

9 FDA recalls on record (2023–2026) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. 2

Potential for internal fastening mechanism within generator of mobile x-Ray to fail. 2

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. 1

Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve d 1

During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the 1

Recalls

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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