Recall Ledger

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 recall (Micro-X Ltd.)

Medical deviceClass IIOngoing

Summary: Micro-X Ltd. is recalling Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71. Reason: X-Ray generator may malfunction resulting in the X-Ray being inoperable.

What is being recalled

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Why

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico. (states named: California, New Jersey, Puerto Rico, Washington)

How to tell if yours is affected

Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1918-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 27, 2026
ReportedApril 29, 2026
CompanyMicro-X Ltd.
Company locationTonsley, N/A, Australia
Initiated byVoluntary: Firm initiated
Quantity32 units

More recalls from Micro-X Ltd. · all medical device recalls · recalls from March 2026

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