Food, drugs, devices › Micro-X Ltd.
Device recall: MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA enforcement event 95617 is a device recall by Micro-X Ltd. of Tonsley, initiated 28 Nov 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Micro-X Ltd. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro-X Ltd., Tonsley, Australia.
Reason for recall
"Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator."
Distribution
"US Nationwide Distribution: NJ, CA, PR"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0665-2025 | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 | 18 | Class II | Ongoing | 18 Dec 2024 |
Context
Other enforcement events for Micro-X Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Mar 2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | Device | Class II | 1 |
| 4 Apr 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover | Device | Class II | 2 |
| 28 Mar 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-r | Device | Class II | 2 |
| 23 Oct 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | Device | Class II | 1 |
| 22 Oct 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Device | Class II | 1 |
| 31 May 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Device | Class II | 1 |
| 31 Aug 2022 | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution: NJ, CA, PR"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.