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

Medical DevicesSource: FDA (device) · Date: 2026-04-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Micro-X Ltd.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Reason / hazard
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Recall initiated
2026-03-27
Code info
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
Product quantity
32 units
Voluntary mandated
Voluntary: Firm initiated
City
Tonsley
State
N/A
Country
Australia
Event id
98644
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