Recalling firm
Micro-X Ltd.
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Firm state
N/A
Product quantity
32 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Product description
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Code / lot 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
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.