Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury de
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Micro-X Ltd. recalled Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Prod… - a moderate-severity action.
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Prod… was recalled by Micro-X Ltd. in April 30, 2025. Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.. Check the official notice for the remedy. Verify recall #Z-1670-2025 with the FDA Devices before acting.
The recall
Micro-X Ltd. issued this moderate-severity FDA Devices recall-Potential for internal fastening mechanism within generator of mobile x-Ray to fail..
- Moderate
- severity level
- 5 units
- affected scope
- Class II
- classification
- April 30, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1670-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1670-2025) was formally reported on April 30, 2025, with the manufacturer initiating the action on April 4, 2025. 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, N/A. Federal records list the affected scope as 5 units.
The documented reason for this recall is: Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Distribution data in the federal record shows the product reached: US: NJ, WA, Puerto Rico OUS: None. 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.
Medical Devices recalls over time
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.
Affected scope
5 units
Related Recalls
6
3 from same agency
Product description
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
Reason for recall
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1670-2025 |
| Date reported | April 30, 2025 |
| Date initiated | April 4, 2025 |
| Recalling firm | Micro-X Ltd. |
| Firm location | Tonsley, N/A |
| Affected scope | 5 units |
| Distribution | US: NJ, WA, Puerto Rico OUS: None |
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.
- Check the recall number (Z-1670-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A. Recalled by Micro-X Ltd.. Units affected: 5 units.
Why was this product recalled? ▼
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1670-2025.
Where was the recalled product distributed? ▼
Distribution: US: NJ, WA, Puerto Rico OUS: None.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1670-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 April 30, 2025. 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.