Brand Name: Rover recallZ-1669-2025 · Micro-X Ltd. · initiated Apr 4, 2025

Why it was recalled

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

FDA root cause category: Device Design

What the company is doing

On April 4, 2025, Micro-X Ltd. issued a "Urgent Medical Device Correction" Notification to via E-Mail affected consignees. Micro-X ask consignees to take the following actions: " Inspect your stock immediately and quarantine affected stock on hand to prevent further use. " Circulate this notice to all users of this device so they are aware of the issue. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please retain this letter with your system(s) documentation. " Please complete and return the attached response form to the Micro-X LTD in Australia: [email protected] and copy [email protected] to reconcile this process no later than 30 days from receipt. Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.

Recall details

Recall number

Z-1669-2025

Status

Open, Classified

Initiated by the company

Apr 4, 2025

Posted by the FDA

Apr 24, 2025

Recalling firm

Micro-X Ltd.

Quantity

13 units

Product code

IZL

FDA submissions

K211423

Distribution

US: NJ, WA, Puerto Rico OUS: None

Product description

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 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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Micro-X Rover

  Micro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)
  3 recalls0 reports

Other devices under the same FDA submission

2 devices cleared under K211423 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Micro-X Rover

  Micro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)
  7 recalls0 reports
• Micro-X Rover

  Micro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 96638).

• Z-1670-2025 · Open, Classified
  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 incorpor…