CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report

Rover Mobile X-ray System, # MXU-RV35 recalled by Micro-X

Micro-X is recalling Rover Mobile X-ray System, # MXU-RV35, distributed nationwide in the US. The recall was initiated on 28 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395

Quantity recalled18

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0665-2025
FDA event ID: 95617
Recalling firm: Micro-X, Tonsley
Classification: Class II
Status: Ongoing
Recall initiated: 28 Nov 2023
FDA classified: 12 Dec 2024
Reported: 18 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

28 Nov 2023	Recall initiated by company
12 Dec 2024	Classified by FDA	+380 days
18 Dec 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Where it was distributed

US Nationwide Distribution: NJ, CA, PR

Nationwide California New Jersey Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395

Where was it sold?

US Nationwide Distribution: NJ, CA, PR

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Micro-X

All 10

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	Rover Mobile X-ray System recalled by Micro-X	Micro-X	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Rover Mobile X-ray System recalled by Micro-X	Micro-X	Device Malfunction	NJ, PR, WA
30 Apr 2025Device	CLASS II	Rover Mobile X-ray System recalled by Micro-X	Micro-X	Device Malfunction	NJ, PR, WA
23 Apr 2025Device	CLASS II	Rover Mobile X-ray System recalled by Micro-X	Micro-X	Device Malfunction	Nationwide
23 Apr 2025Device	CLASS II	Rover Mobile X-ray System recalled by Micro-X	Micro-X	Device Malfunction	Nationwide

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide