Severity
Moderate
FDA Devices recall · Reported December 18, 2024
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, …
Micro-X Ltd. recalled MICRO-X Rover Mobile X-ray System, # MXU-RV19 - a moderate-severity action.
MICRO-X Rover Mobile X-ray System, # MXU-RV19 was recalled by Micro-X Ltd. in December 18, 2024. Reason: During internal testing it was found that if the system is Ready to expose and the hand switch is then droppe…. Check the official notice for the remedy. Verify recall #Z-0666-2025 with the FDA Devices before acting.
The recall
Micro-X Ltd. issued this moderate-severity FDA Devices recall-During internal testing it was found that if the system is Ready to expose and the hand switch is then droppe….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0666-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0666-2025) was formally reported on December 18, 2024, with the manufacturer initiating the action on October 23, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Micro-X Ltd. is listed as the recalling firm, operating out of Tonsley. Federal records list the affected scope as 23.
The documented reason for this recall is: During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a v… Distribution data in the federal record shows the product reached: US Nationwide Distribution: TX, CA, OH, ID, WA, AZ. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
23
Related Recalls
6
3 from same agency
MICRO-X Rover Mobile X-ray System, # MXU-RV19
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0666-2025 |
| Date reported | December 18, 2024 |
| Date initiated | October 23, 2024 |
| Recalling firm | Micro-X Ltd. |
| Firm location | Tonsley |
| Affected scope | 23 |
| Distribution | US Nationwide Distribution: TX, CA, OH, ID, WA, AZ |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 18, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.