Food, drugs, devices › Micro-X Ltd.
Device recall: Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover
FDA enforcement event 96638 is a device recall by Micro-X Ltd. of Tonsley, N/A, initiated 4 Apr 2025 and classified Class II, with 2 product records.
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. 85% of the 945 device enforcement events initiated in 2025 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, N/A, Australia.
Reason for recall
"Potential for internal fastening mechanism within generator of mobile x-Ray to fail."
Distribution
"US: NJ, WA, Puerto Rico OUS: None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1669-2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, 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… | 13 units | Class II | Ongoing | 30 Apr 2025 |
| Z-1670-2025 | 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.… | 5 units | Class II | Ongoing | 30 Apr 2025 |
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 |
| 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 |
| 28 Nov 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 | 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: "Potential for internal fastening mechanism within generator of mobile x-Ray to fail."
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: NJ, WA, Puerto Rico OUS: None"
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.