Brand Name: Rover recallZ-1579-2025 · Micro-X Ltd. · initiated Mar 28, 2025

Why it was recalled

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

FDA root cause category: Device Design

What the company is doing

On March 28, 2025, Micro-X Ltd. issued a "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. Micro-X asked consignees to take the following actions: 1. Continue to use your product as normal in accordance with its intended use. 2. Your local service representative will be in contact to apply this update to the systems at the next site visit. 3. Circulate this notice to all users of this device so they are aware of the issue. 4. If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. 5. Please retain this letter with your system(s) documentation. 6. Please complete and return the attached response form to Micro-X to the Micro-X LTD in Australia: [email protected] and copy [email protected].

Recall details

Recall number

Z-1579-2025

Status

Open, Classified

Initiated by the company

Mar 28, 2025

Posted by the FDA

Apr 16, 2025

Recalling firm

Micro-X Ltd.

Quantity

20 units

Product code

IZL

FDA submissions

K211423

Distribution

US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).

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

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)
  7 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)
  3 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 96518).

• Z-1578-2025 · Open, Classified
  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorpo…